Novel methods of pasteurization enabling the effective total inactivation of viral and bacterial contamination of in-shell chicken eggs through inactivation levels previously unachievable without loss of raw characteristics

ABSTRACT

There is a process which can pasteurize in-shell chicken eggs to inactivate pathogens when present which includes all strains of  salmonella  and all strains of viruses that historically have been known to exist within chicken eggs and currently are known to be evolving into new and separate strains which may cause large quantities of human illnesses unless countermeasures are developed and employed. One such countermeasure is provided through pasteurization of the subject in-shell eggs through pasteurization involving concurrently a secured environment together with a protocol which enables total inactivation of the targeted pathogens whether bacterial or viral without risk of recontamination.

RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationSer. No. 62/104,374, filed Jan. 16, 2015.

BACKGROUND TO THE INVENTION Introduction

US Government official statistics confirm that chicken eggs for decadeshave been the leading cause of foodborne illnesses within the UnitedStates and consistently have referenced the frequency of salmonellacontamination as found within chicken eggs to be 1 egg in 20,000 eggs.

In the late 1990's production of in-shell chicken eggs for consumer useapproximated 3.0 billion dozen-table eggs and separately 1.0 billiondozen eggs were converted into various forms of liquid egg products.

In a report produced by the United Egg Producers a statistic for theproduction of chicken eggs for the prior year was provided. That reportstated that the combination of chicken eggs dedicated to liquid eggproducts together with chicken eggs dedicated for customary table egguses in year 2014 totaled 7.260 billion dozen.

In the late 1990's the Government reported that approximately 1.1million illnesses stemmed from salmonella-contaminated chicken eggs.Concurrently the Government also reported that chicken eggs were thesingle most cause of foodborne illnesses in the United States and theaverage cost per illness was estimated to be $20,000.

In or around 1990 the Government established that liquid egg productwould require a 10-log level of inactivation of salmonella.

In 1997 the author of this patent approached the US-FDA to establish asalmonella inactivation level for in-shell chicken eggs. A seniorofficial at the US-FDA advised that a 5-log level of inactivation ofsalmonella as commonly found within chicken eggs would qualify the tableeggs so pasteurized to display the term ‘PASTEURIZED’ and to eliminatethe required display of the recitation on each egg carton entitled ‘SafeHandling Instructions’.

As indicated approximately one-quarter of egg production in the late1990's estimated to be 1.0 billion dozen was converted into liquid eggproduct and allowed to be pasteurized to a 4-log level of inactivationof salmonella. That 4-log level of inactivation continued to 2009 atwhich time it was changed from 4 logs to 5 logs as required under theUS-FDA sponsored Egg Safety Final Rule.

Notably, the above-referenced US-FDA sponsored Rule specifically allowedknown to be highly salmonella-contaminated eggs so marked to be includedwithin co-mingled liquid egg product.

The above-referenced 5-log level of inactivation of liquid egg productas set by the US-FDA under the Rule of 2009 allows for co-mingling ofso-identified to be highly salmonella-contaminated eggs which equated tothe level of inactivation required for liquid product to be the same asthat required of in-shell eggs as previously provided and referencedhereinabove.

Notably consumption of chicken eggs from 1990 through to thehereinbefore-referenced report from the United Egg Producers recitingproduction of chicken eggs for public consumption to be 7.260 billiondozen continues to be not only the single most cause of foodborneillnesses but also continues to use the source of illnesses to stem from1 egg in 20,000 eggs as being salmonella-contaminated as was reconfirmedin a report authored by the United States Department of AgricultureOffice of Inspector General dated November 2012.

Separate and apart from the reports for each year spanning over twodecades that 1 egg in 20,000 eggs is salmonella contaminated theseparate and long-standing practice of co-mingling two or slightly moreGrade B chicken eggs into each dozen so-marked as being Grade A or GradeAA in-shell chicken eggs without public disclosure continues to bepracticed but was recommended to be discontinued in a 2001 reportauthored by the National Egg Regulatory Officials (NERO) for reasonsamong other reasons that existing bacterial multiplications to highlevels already were present giving cause for high health risks to theconsuming public which not only have been magnified by extensive age ofthe subject eggs but also by manure on shells as confirmed by frequencyof reports concerning stains on eggshells as well as cracks and dentswhich provide for the spread of contamination through the unclean rinsewater employed. Notably, no available record exists as to the US-FDAaltering the referenced Rule of 2009 to conform to the NEROrecommendation that the practice of co-mingling Grade B eggs with GradeA and Grade AA eggs has been discontinued. Significantly, the per capitaegg consumption in the United States roughly equates to 20 dozen eggsper person per annum. The current population of the United Statescontains roughly 45% or 150.0 million persons as having compromisedimmune systems who carry high risk of illnesses at significantly highercosts per illness which in part are caused by salmonella-contaminatedeggs that official publications of record confirm to be the leadingcause of foodborne illnesses within the United States.

Notably and significantly were only one of the two plus Grade B eggsallowed to be contained in each dozen so marked as Grade A or Grade AAof the statistical average of 20 dozen eggs consumed annually per personto cause an illness to each person in the United States consisting of320.0 million persons at an average cost of $20,000. per illness asconfirmed by Government reports on costs per illness for persons ofordinary health the resulting annual public costs would project to be inexcess of $100.0 trillion separate and apart from the eggs otherwiseactually of Grade A quality within the same dozens but otherwisecontaining salmonella contamination at the published ratio of 1 egg in20,000 eggs being so contaminated. If avoidable whether in part or wholethe projected annual cost savings well exceeds the current NationalDebt.

Separate and apart from the statistics provided above regarding theundisclosed co-mingling of Grade B in-shell eggs with Grade A and GradeAA eggs this section addresses the use of a 5-log level of inactivationof salmonella as measured by the Se strain as employed within co-mingledeggs converted into liquid egg product. Specific reference is made toliquid egg product containing co-mingled inferior eggs which include butare not limited to Grade B eggs. Such eggs frequently include oldereggs, shell manure stains which indicate internal transfer, known to besalmonella contaminated eggs, eggs containing checks and dents, returnsof unsold eggs or returns of repackaged unsold eggs all of which whenco-mingled into liquid egg product and pasteurized to a 5-log level ofSe inactivation as enabled by the 2009 Egg Safety Rule sponsored by theUS-FDA remain to give cause for a major and continuing public healthrisk of significant consequence for reason that the public will relyupon pasteurization as providing safety when in fact it is being misleadinto consuming a notoriously unsafe product which never has lost itsannual ranking as the leading food source of illness for a minimum ofthree decades. That described end product consisting of co-mingled eggspasteurized to a 5-log level of inactivation using Se as the measure ofthe salmonella targeted when separately provided to 150.0 millionmembers of the high risk group consuming only six one-egg servingsannually from an average consumption of 20 dozen eggs consumed annuallyper person the annual cost of illness for that group only calculated atthe average cost per illness provided by the Government for healthypersons at a rate of $20,000. per illness equates to an avoidable annualpublic cost of $18.0 trillion.

Were the above-described potential savings to occur such would enablethe funding of free health care for the total public. Since the NationalDebt and unfunded obligations would be retired within the equivalency ofone year funding would be available not only to provide free healthcareto the total population but also public education programs,infrastructure of the country together with improvements and itsmaintenance, military preparedness together with improved veteranspensions and health programs along with research and development ofother avoidable sources of contamination causing both human and wildlifehealth risks would become affordable at great benefits to all elementsinvolved.

In summary, the new art enables the total inactivation of contaminatedchicken eggs containing either or both salmonella and viruses in allstrains and in all projected quantities together with the moreheat-resistant strains of viruses as they may occur withoutconsequential alteration to either the aesthetic, functional ornutritional values of the subject chicken eggs. All of the recitedsignificant benefits to the public well-being are made available througha new art form of pasteurization of chicken eggs which not only providesfor the total elimination of illnesses from chicken eggs but alsoprovides for national savings from debt causing illnesses to besubstituted by surpluses which enable the funding of an improvednational environment.

The background to the areas of new inventiveness claimed herein for thefirst time provides for the effective statistical inactivation of bothviral strains and salmonella strains as commonly found or may come to befound within chicken eggs. The mentioned inactivation results from newinventiveness which in all of its components succeeds in the totalinactivation of current and future derivatives of viruses whose presencewithin chicken eggs presents a public health risk as forecasted by thescientific community to mature into a public health threat of pandemicproportions. Notably, viral inactivation includes the automaticinactivation of salmonella bacteria as found within in-shell chickeneggs as well as its presence within liquid egg product. Both pathogensare considered to be continuing public health risks causing bothillnesses and deaths stemming from their separate or combinedcontamination of chicken eggs.

With regard to the current problems caused by salmonella in the form ofdeviations from separate strains commonly occurring within in-shellchicken eggs and liquid egg product it has been determined that thescope of the problem impacting upon public health is greater than thatwhich the public at large is aware. Certain illustrations of the scopeof the problem are recited below but in part separately result fromunclear and overlapping jurisdictions by agencies charged withoversight.

For introduction purposes certain persistent issues involving failuresin the oversight of chicken eggs produced which in the end can be tracedback to having their root cause to be from overlapping jurisdictionsbetween sub-agencies together with actual failures in the oversightperformed by those agencies regarding their responsibilities to providean end quality of safety of the subject in-shell chicken eggs togetherwith an end quality of safety of liquid egg product which protects thepublic from avoidable illnesses. Separately, outside influences whichinclude lobbyists contribute to the confusion already present betweensub-agencies as to the authority each may have together with the resultsof overlapping jurisdictions and lack of clear and definitiveidentifications of areas of responsibility. As one illustration, in oraround 1990 it was reported that approximately 1.1 million cases ofillnesses caused by salmonella-contaminated chicken eggs had occurred ineach of the recent prior years. The associated cost per illness wasreported to be $20,000. The USDA as the agency of jurisdiction overliquid egg products reported that not one illness had been traced backduring that timeframe to liquid egg products which unlike in-shellchicken eggs were pasteurized. The chronic unsaid was that the originallevel of pasteurization established in the early 1990's was 10 logs forsalmonella as applied to liquid egg products for which products all eggsbeing utilized were pasteurized. When that level of inactivation couldnot be achieved without damage to the raw characteristics of the subjectegg product the log level of inactivation for liquid egg products waslowered to 4 logs as measured by salmonella. Notably, from that timeforward i.e. for some 20 years the public received materially underpasteurized liquid egg products which by implication performed invarious ways by the agency of jurisdiction has mislead the public intobelieving that the liquid egg products were safe when statisticallyduring that same timeframe millions of avoidable illnesses occurred.Notably, during that same timeframe Government agencies continued toreport 1 chicken egg in 20,000 chicken eggs was salmonella-contaminated.Also reports continued to confirm that illnesses had not been reduced ina ratio representing the ratio existing between liquid egg product andin-shell chicken eggs i.e. more or less 3 in-shell to 1 liquid. Hence,the 5-log inactivation of liquid egg product provided no improvement tothe quantity of illnesses and in fact the quantity since has kept pacewith the rate of increase in consumption i.e. 1 contamination in 20,000eggs has nearly doubled through increased production and consumptionjust as if no pasteurization had occurred.

For clarity of understanding, the areas of responsibilities foroversight in 1997 the US-FDA had assumed jurisdiction of in-shellchicken egg pasteurization by virtue of the eggs through pasteurizationbecoming qualified to be a processed food. At that time the inventor ofthe claims provided herein approached the US-FDA with a request toestablish a level of pasteurization of in-shell chicken eggs which hebelieved could be accomplished through new methods invented by him. TheUS-FDA promptly advised that were salmonella within an in-shell chickenegg to be inactivated to a 5-log level, the end product could be labeledas ‘PASTEURIZED,’ and in the end the requirement to display the languageon each in-shell egg carton entitled ‘Safe Handling Instructions’ wouldno longer be required due to the eggs being pasteurized.

That led to the filing of a patent by the inventor through counsel whichwas issued as the U.S. Pat. No. 5,843,505 on Dec. 1, 1998.

The above-referenced 5-log level of inactivation of salmonella, as foundwithin in-shell chicken eggs as set by the US-FDA at the request of thisinventor in 1997, was taken at face value. What was undisclosed by theUS-FDA to the inventor at that time and also unknown to the public atlarge was that the original 10 logs set in the 1990's to inactivesalmonella as found within liquid egg products had been reduced from 10logs to 4 logs, as measured by salmonella, to accommodate the failure ofprocessors to perform the inactivation level required without causingthe liquid egg end product to coagulate.

More recently two separate senior Government agencies commented uponboth various questionable practices and misrepresentations publicized bysubsidiary agencies of jurisdiction over in-shell chicken eggs andliquid egg products. Those agencies identified both misrepresentationsin raw egg safety and misrepresentations in the quality of the endproduct provided by a 5-log level of pasteurization of both liquid eggproducts and in-shell eggs when such employed a 5-log inactivationprotocol of Se. For clarity of understanding the scope of questionableactivities by agencies of jurisdiction certain examples are recited:

1. In a report authored by the USDA Office of Inspector Generalreference is made to the US-FSIS Risk Assessment dated October 2005within which the US-FSIS reported victory over salmonella as foundwithin in-shell chicken eggs through a claim that the mentioned 1 egg in20,000 being salmonella-contaminated had been improved to being 1 egg in277,000.

Notably: The USDA Office of Inspector General in its report datedNovember 2012 discredited the mentioned statistic of the US-FSIS andreconfirmed the statistic of 1 egg in 20,000 in-shell chicken eggs asbeing salmonella contaminated. In that same report it was furtherconfirmed that salmonella was present at a frequency of 1 egg in 20,000eggs which could become as frequent as 1 egg in 3,600 eggs dependingupon the level of contamination being checked. Those levels ofsalmonella contamination would impact upon the otherwise publishedstatistic that 45% of the population representing 150.0 million personsconsists of high risk groups which in the event of an illness could wellexceed $20,000 cost per illness and achieve as much as $100,000. costper illness or even greater under certain circumstances. Although noexact figure has been published it reasonably would be assumed that thatspecific high risk group of 150.0 million persons consuming underpasteurized liquid egg product at an equivalency of six one-egg servingsannually taken from an annual per person average of 20 dozen eggsconsumed would create an avoidable cost of illness per annum for the150.0 million persons in that group equating to $18.0 trillion. Notably,all liquid egg products pasteurized to a 5-log level of salmonellainactivation likely are causes of illnesses.

The US-FSIS is an agency within the USDA. The USDA Office of InspectorGeneral, subsequent to the US-FSIS report, discredited that report andruled that 1 contaminated egg in 20,000 eggs remained to be the accuratedetermination of salmonella contamination within in-shell chicken eggs.Not only did the mentioned report discredit the US-FSIS report, where itreconfirmed both the frequency of salmonella contamination of chickeneggs, but it also reported the following: “Reports by FDA and CDC citeSE as a leading bacterial cause of food-borne illness in the UnitedStates and further cite shell eggs the primary source of human SEinfections.”

As one illustration, the USDA recites claims by liquid egg productproducers that not one illness had been traced back tosalmonella-contaminated liquid egg product.

The inactivation of viruses automatically inactivates all bacteria thatmay be present. Under the new protocol contained within the new art forpasteurization of in-shell chicken eggs, the achievement of 10 or morelogs as measured by viruses is made available without damage to the rawcharacteristics of the subject in-shell chicken eggs.

The new science contains protocols that are employed in a novel mannerwhich when employed in the specific sequence as prescribed creates aunique art form for pasteurization resulting from the conversion ofthose original findings into protocols which preserve the rawcharacteristics of the subject chicken eggs while at the same timeproviding for the inactivation of the targeted pathogens which eliminatetheir risks to public health and allows for safe consumption even whenthe subject eggs are contained within all forms of preparation includingless than hard-cooked or even raw. Notably, the new art substantiallyeliminates the threats to public health as found under all prior art onthe subject of chicken egg pasteurization as currently employed in theUnited States. The current protocols employed for pasteurization ofeither in-shell chicken eggs or liquid products rely upon materiallyless than a 10-log level of inactivation of salmonella in all strains asfound within chicken eggs. Since total inactivation relies upon logsapproaching 10 unless the subject eggs are pasteurized within four daysof lay all current arts for pasteurization of chicken eggs present apublic health risk for reason that it is infrequent that in-shellchicken eggs are consumed within a four-day period from date of lay andare not exposed to ambient temperatures between the date of lay and thetime of consumption. Protocols requiring prompt and deep chilling toavoid potentially lethal multiplication of salmonella within a chickenegg do not eliminate risk but only delay the point in time within whichsalmonella when present succeeds in multiplying to an extent that causesillness. Recent ‘Best buy’ dates employing 30 days have become common.Those ‘Best buy’ dates represent 30 days post packing which may bematerially different from the date of lay. During that period from dateof lay through the end of the “Best buy’ date unless continuously deeplychilled a salmonella-contaminated chicken egg containing one cell ofsalmonella will multiply into lethal quantities by the time the “Bestbuy” date of 30 days expires. As discussed herein before the need fortotal inactivation of the targeted salmonella pathogen together with thepotential addition of viruses is compounded by the blending allowed bycurrent regulations of highly-contaminated chicken eggs into liquid eggproduct which has no hope of becoming safe for consumption when lessthan a 10-log level of inactivation through pasteurization has beenperformed. That problem is compounded when stale eggs are allowed to berepackaged with new dates or when known-to-be Grade B eggs are allowedto be co-mingled into Grade A or Grade AA dozens so-marked.

The protocol employed under the new art replaces a reliance upon lessthan clinically proven protocols claiming safety of chicken eggspasteurized to levels as measured in logs which demonstratably areinadequate to provide permanent levels of salmonella inactivation. Thoseprotocols fail to provide public safety against levels of salmonellacontamination as commonly found within chicken eggs known to requireinactivation well in excess of 5 logs, the current threat posed byviruses and the mistaken reliance upon the improbability of providingfor preservation of existing count levels of salmonella contaminationthrough flawless uninterrupted deep refrigeration to avoid lethalmultiplication of contaminants present as has been employed under priorpractice through to the present which likely results from a flawedsubstitution of avoidance of multiplication of the pathogen as areplacement for the inability to provide true inactivation. No prior artof pasteurization has successfully achieved total inactivation of highlypathogenically contaminated chicken eggs containing contamination ofeither or both salmonella or virus strains as is now found to beavailable through the described new art which uniquely provides for aresult of total inactivation of either or both viral and bacterialcontaminants regardless of the level of contamination contained withinthe subject eggs whether found within both in-shell or co-mingled liquidproduct.

As a separate area of new inventiveness contained herein, a securedenvironment is provided for the subject in-shell chicken eggs to receivepasteurization which enables their statistically total inactivation oftargeted pathogens. The mentioned secured environment is provided by amedium whose unique features eliminate risk from residual contaminationcaused by the presence of contaminants residing within thepasteurization medium or within or upon the subject eggs surviving thepasteurization protocol employed as was and continues to be experiencedunder prior arts for pasteurization of in-shell chicken eggs. The newart eliminates the potential for residual contamination as well asrecontamination through multiple features described in greater detailelsewhere herein under the section entitled ‘Detailed Description of theInvention’.

The new art as reported and described herein consists of two primaryareas of inventiveness, which when employed in tandem, provide for newand unique levels of pasteurization of targeted pathogens, which includeeither or both viruses and salmonella bacteria as are found or may cometo be found within in-shell chicken eggs.

The first of the primary areas of inventiveness consists of a uniqueapplication of heat and its denial, which provides for an ability toapply heat through a predetermined formula customized to accommodate thespecific egg characteristics of the targeted eggs to achieve totalinactivation of pathogens, which may be present whether bacterial orviral without risk of consequential loss of aesthetics, functionality orthe nutritional benefits characteristic to a raw chicken egg. Thisportion of the new protocol may be referred to from time to time withinthis document as ‘cyclical’ in its nature.

The described first primary area of inventiveness referenced aboveconsists of a unique method for the application and denial of heatadjusted to accommodate the specific characteristics of the in-shellchicken eggs subjected to pasteurization which is accomplished throughnovel uses of heat and induced chilling to provide pasteurization toin-shell chicken eggs at levels as measured in logs never beforeachievable without consequential loss of the raw characteristics of thesubject eggs.

For clarity of understanding, the protocol employed is preprogrammed toaccommodate specific timeframes and temperatures to which the subjecteggs are exposed. Those steps enable pasteurization to occur at loglevels never previously achievable without damage to the subject eggs.All of which is performed within a uniquely secured environment withinwhich pasteurization occurs from inception through conclusion accordingto the referenced preprogrammed protocol which is performed within anenvironment that uniquely is secured against contamination orrecontamination throughout the duration of the pasteurization protocolbeing employed. Here follows a description of the pasteurization mediumemployed together with its purpose and features.

The second of the primary areas of inventiveness consists of a uniquepasteurization medium, hereinafter referred to as the ‘medium’, withinwhich total inactivation of targeted pathogens is performed without lossof or damage to the aesthetic, functional or nutritional characteristicsas found within a raw chicken egg.

The described second primary area of inventiveness as referenced aboveconsists of novel features contained within a new and unique mediumwithin which pasteurization achieving the targeted and programmedinactivation of pathogens is performed to predetermined levels asmeasured in log levels peculiar to the inactivation level required forthe pathogen to be inactivated without risk of recontamination as hasplagued all prior art. The unique features of the pasteurization mediumprovide for pasteurization to occur free from risk of recontaminationwhich is made available through added elements to the medium as detailedherein below which become both incorporated and included as integralelements to a formula which provides for an automated program forpasteurization resulting from a customized formula created from a baseformula which arranges for the use of the mentioned elements within themedium to be continuously employed through adjustments which accommodatethe flexibilities containing time and temperature requirements of theintermittent application of heat and its denial which in the end enablesa new and unique ability to pasteurize chicken eggs containing differentcharacteristics and different pathogens to higher levels that achievetotal inactivation of the targeted pathogens as measured in logs whileretaining characteristics found within a raw chicken egg which includeaesthetics and functionality but contains the notable absence oftargeted pathogens.

In summary, the above-described protocol containing a new method ofpasteurization performed within a unique medium when employed togetherrepresent a unique protocol for reliable and total inactivation ofpathogens targeted whether bacterial or viral without the loss of eitherfunctional or nutritional benefits as commonly found within chickeneggs.

The background for the need to provide the public with safety fromcontaminated chicken eggs includes their use in foods which contain bypreference and usefulness raw or undercooked chicken eggs. The historyof the efforts to eliminate salmonella from chicken eggs as a publichealth risk in a formal sense likely began with the need to protect thepublic from food poisoning caused by salmonella as may be containedwithin liquid egg product through the initiation of pasteurizationstemming from the USDA requirements set at a 10-log inactivation ofsalmonella in the 1970's through the Egg Products Inspection Act underthe sponsorship of the USDA

The following represents a more complete history regardingpasteurization of chicken eggs than was provided at the beginning ofthis section under the title of “Introduction”:

1. An original log level of inactivation of salmonella was establishedto be 10 logs.

2. The log level established as 10 logs was to be applied to liquid eggproduct including co-mingled whole eggs.

3. Liquid egg processors in significant part processed the liquid eggproduct taken from co-mingled in-shell eggs and passed that productthrough heated tubes to achieve the targeted log reduction of salmonellaoriginally set at 10 logs.

A problem occurred for the processing in the above-described manner inthat the heated tubes were cooking i.e. causing coagulation of theliquid egg product within the tubes during the process of achieving thetargeted 10-log level of inactivation of salmonella when present.

4. Without current availability of public records confirming such, nonotice on record has been available to confirm that the USDA, as theAgency of jurisdiction, relaxed the log level from the needed 10 logsfor inactivation of salmonella as found within liquid egg product to 4logs, which enabled the elimination of coagulation occurring at a 10-loginactivation protocol to eliminate salmonella to one which required onlya 4-log level. That protocol consisted of converting the subject eggs tobe pasteurized into liquid egg product by allowing that product to flowthrough tubes which were heated to transfer heat for pasteurization tobe performed on the liquid egg product as it flowed through the heatedtube. The reduction from 10 logs to 4 logs enabled the liquid eggproduct to benefit from a reduced exposure to heat by more than 50%which enabled the protocol of employing a heated tube to continue withthe new benefit of having eliminated coagulation of the end productwhich resulted from the reduced exposure of the subject eggs to heatwhich in turn reduced the level of pasteurization and its inactivationof the targeted salmonella bacteria. That reduction solved the problemof coagulation but created the problem of inadequate pasteurization.

5. Notably and mistakenly, the H3N1 virus as found within chicken eggsstemming back to the beginning of pasteurization of liquid egg productwas treated as having the same level of heat inactivation as that ofsalmonella. In both cases i.e. the mentioned virus and salmonella the4-log inactivation of salmonella was employed to the eggs potentiallycontaminated with either or both bacteria and viruses, and the flocksfrom which the eggs came were destroyed. Hence the inactivation of thevirus and salmonella shared the same levels of inactivation. The aboveenabled two errors to occur. First, the salmonella strain was identifiedto be Salmonella enteriditis (Se) which as it turns out was not the mostheat-resistant strain of salmonella as found within chicken eggs.Secondly, the H3N1 virus is part of a family of viruses which sciencesince has identified as requiring at least a 2-log level of inactivationover that of salmonella. The practice of inactivating both salmonellaand the H3N1 virus at a 4-log level as measured by Se continued throughthe enactment of the Egg Safety Rule of 2009.

The above-mentioned practice of employing a 4-log inactivation level forall strains of salmonella for pasteurization of liquid egg producttogether with the H3N1 virus, when present, continued through theeffective date of the Egg Safety Rule of 2009, within which thementioned 4-log inactivation of Se used as the prior measure for allstrains of salmonella was altered to become 5 logs. That level ofinactivation of Se paralleled the level of inactivation set for in-shellegg pasteurization protocol being developed for in-shell chicken eggs bythis inventor, Davidson, as set by the US-FDA at his request in 1997.

6. The continuation of the disposition of chickens and their eggsafflicted by the H3N1 virus continued to be provided with the same levelof heat inactivation as salmonella through to the enactment of the EggSafety Rule of 2009, at which time all references to the H3N1 virus weredropped.

Notably, shortly thereafter a contract was provided to an independentfirm i.e. a subsidiary of Sanofi Pasteur for $150 million to produce avaccine to protect the public against a pandemic forecasted by the WorldHealth Organization (WHO) to be already within the making resulting fromthe ‘H’ series of viruses which were in the process of spreading acrossthe Far East and into the Middle East as well as Europe causingillnesses which if mutated as forecasted to likely occur would providefor human-to-human transfer of illness resulting in a pandemic ofgreater proportion than the Pandemic of 1918 which killed between 50 and70 million persons around the World including 15 million Americans.

Notably, the World population in 1918 approximated one-third of thecurrent population.

WHO has continued to characterize its forecast for a pandemic to be oneviral mutation away from allowing its transfer to be from human tohuman. However, although the speed of transfer would be increased byhuman-to-human transfer as caused by air or saliva and other forms ofdirect transfer the potential scope of the pandemic absent ofhuman-to-human transfer excepting speed likely would remain constant.

Still more notably, in 2009-2010 a pandemic here in the United Statesoccurred from a viral source which according to WHO sickened 60 millionpersons and caused 12,000 deaths in a matter of 12 months.

7. Under current protocol as sponsored by the US-FDA, in-shell chickeneggs if pasteurized to a 5-log level using Se as the measure forsalmonella contamination may display the term ‘PASTEURIZED’ and maydiscontinue the display of the language described on chicken egg cartonsunder the heading of ‘Safe Handling Instructions’ which forewarn thatchicken eggs may be harmful to one's health if less than hard-cooked.

Since 45% of the population of the United States is categorized to bewithin a high risk group which contracts illnesses with greaterfrequency and with greater severity, it is now evident that a 5-loglevel of inactivation of Se is at best a significant risk to that 45% ofthe population and remains to be a risk to the other 55% of thepopulation. It is obvious that a significant health risk fromcontaminated chicken eggs exists and that risk is not being conveyedcommensurately to the public at large.

As one example of minimizing the continuing risk described above theUS-FSIS, a division of the USDA, in 2005 claimed that only 1 egg in277,000 eggs contained a risk of causing illness from salmonellacontamination. That claim was found to be unsubstantiated by the USDALegal Department.

In 2009 the US-FDA within its Egg Safety Rule raised the log level ofpasteurization of liquid egg products from 4 to 5 as measured by Se andnotably concurrently allowed known-to-be and so-marked to behighly-contaminated chicken eggs to be co-mingled into liquid eggproduct bearing the label as ‘PASTEURIZED’ when no statistical supportexisted that a 5-log level of inactivation of Se would succeed inproviding reliable safety to the public at large including those risksto food safety as encountered by interrupted refrigeration frequentlyoccurring between farm to table.

8. The USDA Office of Inspector General in a Report dated November 2012reconfirmed the statistic originally generated by the USDA that onein-shell chicken egg in 20,000 carries with it salmonella contaminationto a level giving cause to illness. That Report reconfirmed thefrequency of potential illnesses and deaths to the same level reportedto be present throughout the 1990's. Significantly, neither thereferenced reports from the USDA Office of Inspector General nor theUS-FDA-sponsored Egg Safety Rule of 2009 addressed the seldom disclosedpractice of including a statistical average of 2.16 highly-contaminatedGrade B eggs being included within each dozen of so-marked Grade A orGrade AA eggs as reported and confirmed by the National Egg RegulatoryOfficials (NERO) in their report to the US-FDA which was authored priorto and provided to the US-FDA before their Rule of 2009. Nonetheless theUS-FDA went forward under their Rule in allowing a continuation ofco-mingling Grade B eggs with Grade A eggs whether in liquid egg productor whether within pasteurized in-shell egg cartons as well as within rawegg cartons. Notably, when pasteurized to 5-logs the Grade B eggs werenot inactivated from their salmonella contamination. Similarly, when thementioned Grade B eggs were co-mingled with Grade A eggs within eggcartons the risk to the public health was both disguised andsignificant. Further, when co-mingled into liquid egg product a 5-loglevel of inactivation of Se had no hope for the consuming public to beout of harm's way of illnesses.

8. For further emphasis to the public risks described above thefrequency of illnesses caused by Grade B eggs co-mingled with Grade Aand Grade AA eggs, so labeled, as provided to the public at large whichincludes 45% of the population as being members of high risk groups is aseparate and distinct source of illnesses caused by salmonella levels asfound within chicken eggs which are not inactivated reliably by anythingless than a 10-log level of inactivation as measured by the strain ofsalmonella identified as Se and as designated by the US-FDA as thestrain of measure to be employed. When consumed without the benefits ofpasteurization the risks described to the mentioned risk group magnify.Therefore

9. Notably and significantly, were only one of the two plus Grade B eggscontained in each dozen of the estimated 20 dozen consumed annually perperson to cause an illness three times annually to each person in theUnited States consisting of 320.0 million persons at an average cost of$20,000. per illness as per Government reports on costs per illness theresulting potential annual cost savings would be $19.2 trillion. Also

10. Although no exact figure has been published, it reasonably would beassumed that that specific high risk group of 150.0 million personsconsuming under pasteurized liquid egg product at an equivalency of sixone-egg servings annually taken from an annual per person average of 20dozen eggs consumed would create an avoidable cost of illness per annumfor the 150.0 million persons in that group equating to $18.0 trillion.

11. The total of the avoidable cost referenced in numbers 10 and 11above equates to $37.2 trillion annually.

12. According to the United Egg Producer's report on the quantity ofchicken eggs produced for market, 7.260 billion dozen were produced foryear 2014. The public cost for providing 100% pasteurization benefits to100% of the quantity of the eggs recited at full retail is projected tobe $2.614 billion.

13. Not only did the 5-log level of inactivation of known to be highlysalmonella contaminated and co-mingled chicken eggs continue to beprovided to the public under the authorization provided by the US-FDAbut also the US-FDA sponsored Rule of 2009 through to the presentnotably and specifically included the addition of known to be highlycontaminated eggs whose contamination levels well exceeded anypasteurization protocol in practice which rarely if ever were totallyinactivated by a 6-log level of pasteurization even were such to beemployed as at that time was recommended to the US-FDA by the US-FSIS.It is important to note that pasteurization even at 6-logs minimum was4-logs shy of providing reliable inactivation.

The current and reliable standard for salmonella inactivation requires aminimum of 10-logs which will inactivate all current and forecastedstrains of salmonella together with the levels of contamination existingwithin the subject egg being processed for pasteurization which includesknown to be highly contaminated eggs so identified by the US-FDA andknown to be Grade B eggs representing 18% of each dozen which too areboth inferior in quality and contain high levels of salmonellacontamination.

The above recitation provides for an understanding of the currentinadequacies of both Government oversight of chicken eggs fromprocessing to consumption as particularly noted in detail within theUSDA Office of Inspector General report of 2012 as complemented by agroup of experts known as the National Egg Regulatory Officials (NERO)which in a report more fully discussed herein below confirmed numerousabuses within the egg industry placing the public in harm's way thatmost particularly impacts upon the 45% of the public that are members ofrisk groups which gives cause for greater severity and frequency ofillnesses from a contamination source which is typical of that foundwithin chicken eggs through salmonella together with new threats fromviral contamination.

Significantly, within the referenced NERO report the practices ofrepackaging eggs with stale dates altered to reflect a more current dateas well as the practice of including within a dozen Grade A or Grade AAeggs to include Grade B eggs of up to 18% is confirmed to exist and morenotably is undisclosed to the consuming public at large. Notably, theNERO report further states that Grade B eggs are older and may containmaterially higher levels of contamination. More generally NERO reportsthat the inclusion of Grade B eggs co-mingled with Grade A or Grade AAeggs should be discontinued for reasons of their low quality and highhealth risks to the public. No information researched as of 2015confirms a change in the policies recommended by NERO as having beenperformed by either the USDA and its associated agencies or the US-FDAWere such Grade B eggs to carry a pathogen consisting of eithersalmonella or a virus the cell counts frequently would exceed a 5-loginactivation of Se thus causing massive quantities of illnesses to ahighly vulnerable population that includes approximately 150.0 millionpersons within the compromised immune system category.

Some reliance upon processing or pasteurization occurring within fourdays of lay has been discussed as an off-set to the need forpasteurization to protect against illnesses. Unfortunately, that natureof reliance upon an industry that is so diverse in its nature ofhandling eggs from farm to table together with its demonstrated trackrecord of delivering over a span of decades substandard product makesmoot any reliance upon the industry being self-governing and equallymakes moot reliance upon Government agencies to provide reliableoversight.

Notably and materially under the new inventiveness the effectiveinactivation of new and deadly virus strains as may be found or come tobe found within chicken eggs is enabled. Such inactivation includes butis not limited to current viral strains identified as the H5N1, H7N9 andthe H7N7 along with additional strains which in part find their genesisfrom the mentioned H5N1 or are the result of independent virus strainsnot yet fully identified. Successor virus strains evolving independentlyor through mutations according to science are expected to give cause foreven greater risks to public health through their new abilities tospread from one living thing to another. Potential successor strains maybe the result of new strains stemming from two separate viral groupings.One grouping is highly pathogenic while the other grouping is of lowerpathogenic risk. Said referenced strains and their groupingsindividually and historically may co-mingle to form strains which arenot identical to prior strains but may flourish independently or postco-mingling as currently reported by the scientific community throughits publications. Accordingly the nature of the characteristics of thesubject viral strains confirm the continuing evolution of viruses. Asexamples of what either is occurring or has been determined to likelyoccur along with described countermeasures to protect against chickeneggs contributing to a forecasted pandemic caused by the evolution ofthe virus strains reported to either already exist and to contaminatechicken eggs resulting from on-going evolutions such is expected toenable human-to-human transfer of an Avian Influenza strain throughcontinued evolutions or independent creations of new strains. The commondenominator for both viral and bacterial inactivations when presentwithin or upon chicken eggs has been proven to be the application ofheat to a level and duration which inactivates the targeted pathogen.

Although water is the preferred heat transfer medium when employedwithin the art contained herein which includes spray alternatives forheat generation and conduits are available to be employed in concertwith the conveying medium to achieve log reductions necessary toinactivate targeted pathogens requiring log reductions greater than allcurrent art enables without damage to the raw characteristics of thesubject eggs together with maintaining their nutritional benefits. Thosealternate sources of heat generation may include but are not limited toheated water in any form which may be supplemented by each or all ofmicrowave applications, reverse osmosis, ultraviolet light beamsincluding other beamed energy sources passing through air but willusually include purified water as the preferred base-conveying medium ofenergy sources as known within the scientific community to be effectivein creating and transferring heat through an evenly applied source ofenergy without damage to the subject food being processed whilemaintaining the aesthetic and functional characteristics of the subjecteggs being pasteurized.

The targeted pathogenic microorganisms may differ in their heattolerance. However, the new technology as devised and described hereincontains a unique feature which provides for an increase to the range ofinactivation or destruction of the targeted contaminants through aunique protocol involving both the application of and the denial of heatin a manner which employs both levels of heat application and levels ofheat denial in a unique manner which enables total inactivation of thetargeted pathogens with minimal impact upon the nutritional, aestheticand functional qualities of the treated chicken eggs as compared tothose of raw chicken eggs. The application of heat and its denial isperformed on a gradual basis initially but may be accelerated forimproved results. The initial gradual heating and cooling beforeacceleration provides protection against certain eggshells which aremore fragile in their composition from cracking as may be caused bytemperature changes of the eggs including their composition which bothexpands and contracts to a greater extent when temperatures provided toit are abrupt.

Notably and significantly the application of heat to contaminatedchicken eggs is not inventive unto itself. It has long been known thathard cooking chicken eggs eliminates risk of illness stemming fromeither or both bacterial and viral contamination. More recently the artof utilizing heat through a medium including but not limited to waterhas been employed to perform pasteurization of both liquid egg productand in-shell chicken eggs. Those attempts were successful in performinga level of pasteurization targeting bacteria as found within chickeneggs but failed to achieve total inactivation of all strains ofsalmonella and any strain of viruses without giving cause for the lossof functionality as found in raw chicken eggs as well as the aestheticloss of their raw characteristics.

What is novel in the instant case of this Application is that the levelof pasteurization required to inactivate all strains of both virusesthat may come to be found within chicken eggs together with salmonellabacteria as currently found within chicken eggs and particularly thoseeggs that have had time within either a commercial or noncommercialenvironment as may occur from farm to table to multiply their counts ofeither of the mentioned pathogens when present to reach either a lethallevel of contamination or an illness-causing level of contaminationwhether from salmonella or viral sources requiring materially higherthan a 5-log pasteurization protocol as applied to either salmonella orviruses to be effective in providing the necessary levels ofinactivation of both mentioned contaminants when present eitherseparately or concurrently to assure public safety has been fullyachieved i.e. total inactivation without either the necessity ofhard-cooking or the need for extremely prompt and uninterrupted deepchilling continuing from lay through consumption. Such is consistentwith the spirit, intent and language provided by the US-FDA in adocument entitled ‘Egg Product Inspection Act’ dated May 20, 2009, whichin pertinent part states: “The term “pasteurize” means the subjecting ofeach particle of egg products to heat or other treatments to destroyharmful viable microorganisms by such processes as may be prescribed byregulations of the Secretary”. Notably, the Egg Safety Final Rule datedJul. 9, 2009, allowed for so-identified and known to be highlycontaminated chicken eggs to be pasteurized to a 5-log level ofSe-inactivation and to be so labeled as ‘PASTEURIZED’ while at the sametime eliminating on egg cartons or liquid egg product containers therequired display of ‘Safe Handling Instructions’ which forewarned thereportedly estimated 150.0 million persons who were likely egg consumershaving compromised immune systems that unless eggs were hard-cooked suchcould cause either illness or death. Notably and pertinently no reliablehope or scientific evidence either existed or currently exists thatsalmonella in all of its strains as found within chicken eggs includingthose eggs which are known to be highly contaminated can be inactivatedand stay inactivated from farm to table when a 5-log inactivation of Seis used as the pasteurization standard employed. Still more notably theUSDA Research Laboratory located in Athens, Ga., is the source ofstudies which include and confirm that the level of inactivationrequired of salmonella-contaminated chicken eggs is successful when thequantity of exposure to heat provides for total inactivation. The USDAstudies confirm that absent of uninterrupted deep chilling from time oflay through consumption in a matter of 31 days of exposure to generallyambient temperatures the cell count of salmonella if present at time oflay in an original quantity of 3 cells can multiply to a cell countexceeding 1 billion cells. When the above statistic is applied toreliance upon very prompt and deep chilling of the subject chicken eggsfrom farm to table whether raw or partially pasteurized it is obviousthat the reliance upon deep chilling to restrict multiplication ofeither or both bacteria and viruses to a level that does not give causeto illness when consumed at less than hard-cooked is a futile effortwhich represents serious consequences to an unsuspecting public thatcontains approximately 45% of the population as being within thecategory identified as the ‘high risk group’. The above-describedcollective deficiencies in providing the public with a safe egg whetherin-shell or in liquid form further is notably and significantlycompounded by the allowance of dangerous and ineffective practicesinvolving deceptions in the labeling of eggs which place the public atstill greater risk of illness caused specifically by allowing known tobe contaminated, cracked or dented eggs to be sold to the consumeralthough such can be avoided and allowing Grade B eggs at a certainratio specifically allowed to be up to 18% to be co-mingled with Grade Aand Grade AA eggs within cartons so-marked to be passed on to anunsuspecting consumer. Those matters among others of long practice arediscussed in greater detail within a document whose excerpts are recitedherein directly below.

In a current report NERO confirmed that eggs passing through the currentsystem from date of lay through date of consumption frequently achieveda 60-day age which included an allowed repackaging of stale eggs whichwhen practiced allowed for an additional 60 days as discussed by NERO inits report concerning the need for new regulations to eliminate thatpractice which has not occurred. On those occasions the age of the eggsprior to packaging frequently would equate to 60 days or greater. Thequantity of salmonella cells enabled to be present at minimum required a10-log reduction for inactivation. Independent sources includingscientists attached to the USDA confirm that eggs contaminated withinfluenza strains require still greater levels of inactivation than dosalmonella strains. For decades public information provided through avariety of authorized Government agencies of jurisdiction have reportedthat salmonella-contaminated chicken eggs is the leading source offoodborne illnesses. The problem of providing food safety for the publicis compounded by misleading practices within the egg industry whichinclude the labeling of the ‘Best By’ or ‘Sell By’ dates, hereinafterreferred to as ‘Best By’, to start at the date of packaging. The ‘BestBy’ date not only runs from the date of packaging and not the date oflay but also has been extended from what used to be a range between 14days and 21 days post-packaging in most cases as state jurisdictionsprovided to now allow for 30 days from date of packaging.

As the report from NERO confirms, the current practice employed allowsfor Grade B eggs to be co-mingled with Grade A and Grade AAunpasteurized shell eggs. Not only is the described practice of blendingGrade B eggs with Grade A or Grade AA eggs on its face inconsistent withthe purpose of grading but also that practice creates a vehicle forproviding the public with false representation as to the quality of theeggs together with their potential level of dangerous contaminationbased upon their preconditions at origin and age. Further and equallynotably stale eggs are allowed to be repackaged and re-dated without anynotice to the consumer that such has occurred. Still more notably theNERO report confirms that food service eggs are not subject to any daterequirement whatsoever as such relates to either date of lay or ‘BestBy’ as guidelines to the enterprise serving an unsuspecting public whichon its face includes nearly one-half the population categorized as beingpart of a high risk group having reduced immune systems giving cause forgreater risk of illness from consumption of pathogenic foods.Significantly, it is common knowledge throughout Government and the eggindustry that each year chicken eggs are acknowledged to be the leadingsource of illness among all food groups. That common knowledge as NEROpoints out in its report is flaunted by practices performed by agenciesof jurisdiction.

The above-described shortcomings regarding a 5-log level of inactivationof Se as being ineffective in inactivating salmonella cell quantitieswhich frequently are present as enabled through the mentioned Rule andas particularly applied to the mentioned vulnerable 150.0 million eggconsumers with compromised immune systems now are resolvable.

The statistical confusions over the frequency of salmonellacontamination of chicken eggs, together with confusion over theirsources of contamination, for at least three decades remain unresolved.However, the subject eggs continue to be represented as being safe forconsumption for the public when less than hard-cooked as is assured byagencies of jurisdiction providing that the eggs have been pasteurizedto a 5-log level of inactivation of the salmonella strain identified asSe. Separately and significantly after achieving only a 5-log level ofinactivation of salmonella as measured by the strain Se which is not themost heat-resilient strain the agencies of jurisdiction have allowed fortheir inclusion both within in-shell egg cartons or within liquid eggproduct labeled as ‘PASTEURIZED’ when nonesuch achievement has beenperformed under the 5-log protocol employed. In part the confusionreferenced primarily pertains to whether the salmonella-causing illnessstems from contaminated eggshells or the ovaries of the chicken.Although the source may be a matter of contention as to the quantity orthe frequency of contaminated eggs the health of the chicken has hadlittle attention as to its vulnerability to illness including itsbecoming a salmonella carrier. Separately, it is common knowledge thatthe eggshell is exposed to hen manure and environmental contaminationflowing into the egg post-lay through its shell pores as the internalegg contracts through exposure post lay to its new and coolerenvironment. The ability to provide the public with a pasteurized eggwhich overcomes the risk of airborne recontamination post pasteurizationas now provided by Davidson within this application together with thechallenge to provide a clinically proven safe egg when consumed lessthan hard-cooked has become a broader problem than just the vehicle ofpasteurization employed since the very level of pasteurizationestablished by the Government knowingly has been inadequate to providethe public with the safety it deserved without the necessity of theirreliance upon incomplete information placing their health, wealth andlives at serious risk. For clarity and at risk of redundancypasteurization of liquid egg product began with a 10-log inactivation ofsalmonella as found within chicken eggs or upon their shells. Whencoagulation occurred during processing employing heat the 10-log levelof inactivation through the application of heat was relaxed to 4 logs.No substitute for the missing 6-log reduction was provided to replacethe reduction in the level of safety of the end product as applied tothe new level of risk being passed through to the public. As a resultsalmonellosis from chicken eggs became the single most source offood-borne illness each year over the past three decades. Part of theunsaid within that well-publicized statistic was the statisticalpresence of illnesses from liquid egg product which had a long-standingreputation for being created from cracked, dirty, misshapen, stale,un-refrigerated and known to be both highly contaminated andrecirculated old eggs co-mingled and blended into various types ofliquid egg products which rarely gained the benefits from prompt, deepand sustained refrigeration. That product consistently has representednearly one-third of the in-shell chicken egg industry currentlyapproximating more than 2.25 billion dozen annually by itself. Since therelaxation of the log level required for pasteurization of liquid eggproduct from 10 logs to 4 logs which accommodated the inability topasteurize to the level of safety achieved at 10 logs withoutcoagulation of the end product it is notable that the industryrepeatedly has claimed not one illness from salmonella-contaminatedliquid egg product has been traced back to that source. It is pertinentthat during the 1990's to the present chicken eggs have remained theleading cause of foodborne illness. Since as mentioned approximatelyone-third of all chicken eggs are converted into liquid egg product andthat product being pasteurized occurred during that same timeframe goingback to the 1990's it can be concluded that the quantity of illnesseswould have reduced in their ratio to the total production of eggs. Nosuch reduction has occurred. What actually has occurred is that thenumber of illnesses remains to be at a ratio of 1 egg in 20,000 eggsbeing contaminated from a salmonella source either present within orupon the subject eggs separate and apart from those co-mingled toprovide for liquid egg products. The ratio is stagnant althoughproduction over the years has doubled. In summary, none of the claims ofimprovements to public health from eggs have occurred, and eggs remainto be the single most source of foodborne illness each year as so overthe prior twenty years as repeatedly has been confirmed by theGovernment itself in reports published. Separately and clearly theco-mingling of known to be highly contaminated chicken eggs frequentlyresulting from rejected eggs, unsold eggs of stale dates, returned eggsof unknown dates together with common abuses to eggs ending up withinliquid egg products co-mingled and pasteurized to a level ofinactivation of 5 logs using Se as the measure holds little hope of notcausing illness at least to the 45% of the national populationrepresenting 150.0 million persons identified as being of impairedhealth and having high risk of compromised immune systems causing bothmore intense illnesses at greater frequency as well asdisproportionately higher costs per illness. That minimal frequency ofillnesses as applied to members of the high-risk group only but using areduced cost per illness as published by the US-FDA applicable topersons of good health i.e. $20,000. per illness projects into anavoidable public cost for only the members of the high risk groupequating to $18.0 trillion annually.

In summary to the above, the following applies toinadequately-pasteurized liquid egg product containing co-mingled eggscarrying salmonella at a variety of levels of contamination along with avariety of strains of salmonella all as known to exist and allowed to beconsumed by the public by regulation as monitored by agencies ofjurisdiction. Irrespective of the level of contamination of the subjectchicken eggs being converted into liquid egg product, the subject eggsare pasteurized to a 5-log level of inactivation of Se in conformancewith the Government agency standard employed regardless of the source,age, strains of salmonella and the individual conditions surrounding thehistory of the subject eggs. The following comments contain a caveatthat a 5-log level of pasteurization targeting Se for inactivation ofthe quantity of salmonella as found within co-mingled and contaminatedliquid egg product is inadequate to inactivate the described levels ofsalmonella frequently present. Further to the above, the cost ofillnesses for persons of compromised immune systems a/k/a high-riskgroups for these purposes has been modified downward to $20,000 perillness to equate to the cost per illness carried by the US-FSIS forpersons of ordinary health. This illustration employs levels ofconsumption per capita as applied to solely members of the 150.0 millionpersons which represent all of those who have compromised immune systemsas identified by the Government. For these illustration purposes andwith the intention to provide a collection of statistics that are eitherthose of the Government or modified only to be ultraconservative thefollowing calculations and conclusions are provided. The calculationsemploy statistics authored by Government agencies with only one addedassumption which is found within the frequency of individual risk groupmembers consuming liquid egg product prepared in a manner resembling abreakfast serving each composed of a 1 egg equivalent at an averagefrequency per person equating to 6 servings each 12 months. Thefrequency of consumption knowingly and deliberately is understated to bebelow what statistics confirm to be a higher per capita quantity ofconsumption of liquid egg product. The underlying reason for thementioned understatement is to avoid any risk that the quantity ofillnesses generated by inadequately pasteurized chicken eggs employing a5-log level of inactivation of Se has been overstated i.e. if thequantity of consumption were to be increased to more expected actuallevels the frequency and the costs of illnesses may become too great forgeneral understanding and more likely would become suspect. For furtherclarity of the above annual modified per capita quantity of consumptionof liquid egg product recited the per capita consumption of chicken eggsin the United States exceeds 20 dozen per annum per person. Using anaverage of six 1 egg servings each 12 months per person containing theequivalency of 1 egg per serving as provided from already preparedliquid egg product pasteurized to a 5-log level of inactivationcontaining Se as the targeted pathogen the annual number of servingswhether in whole egg dishes or egg dishes containing no yolk toconsuming persons of compromised immune systems would equate to 900million servings. As is demonstrated through official scientific studiesby agencies of jurisdiction a 5-log level of inactivation of Se as thesalmonella strain selected to be most representative is blatantlyunreliable to provide the public with a safe end product when using thementioned level of inactivation of 5-logs as measured by Se. Thereforeco-mingled liquid egg product enabling chicken eggs containing known tobe high levels of contamination which usually is salmonella to be notonly co-mingled into liquid egg product but also to be pasteurized to alevel of a 5-log inactivation as measured specifically by Se clinicallyis known to be inadequate to provide the public with safety forconsumption if less than hard-cooked. In summary, 150.0 million personsconsuming an average of six one-egg liquid egg product servings eachtwelve months pasteurized to the Government requirement of a 5-log levelof inactivation of salmonella (Se) likely would create a public illnesscost of $18.0 trillion per annum just for that portion of the populationand that portion of eggs consumed.

In a report authored by the legal department of the USDA dated November2012, the frequency of salmonella contamination of chicken eggs wasreconfirmed to be 1 egg in 20,000. That statistic conformed to thefrequency of illnesses as being 1 egg in 20,000 as published by the USDAin the 1990's. In the 1970's, the USDA established a standard forpasteurization to rid chicken eggs from salmonella contaminationemploying a 10-log reduction of salmonella without specification of thesalmonella strain. The US-FSIS in the mentioned 2005 Summary recommendeda 6-log reduction for the elimination of Se within liquid egg product.In 2009 the US-FDA in its Egg Safety Rule changed the level ofpasteurization for liquid egg product from 4 logs to 5 logs as measuredby Se. Such applied to both in-shell eggs and liquid egg product whichplaced the level of pasteurization as measured in logs to be the samefor each grouping of eggs i.e. in-shell eggs and liquid egg product. Thenotable difference between the two is that liquid egg product requirespasteurization albeit inadequate and in-shell chicken egg pasteurizationis voluntary but too is inadequate on its face. Notably the reduction ofthe requirement for liquid egg products to be pasteurized at a 10-loglevel to inactivate salmonella to a 4-log level of salmonellainactivation without public knowledge preceded the mentioned Rule of2009 within which the change for liquid egg products from 4 logs to 5logs occurred.

The genesis of the 5-log reduction of Se for in-shell eggs occurred in1997 when Davidson approached the US-FDA seeking a level ofpasteurization for in-shell chicken eggs. The US-FDA promptly andofficially advised Davidson that a 5-log inactivation of Se wouldqualify the eggs to be labeled ‘PASTEURIZED’ and would not be requiredto display a public safety statement referred to as ‘Safe HandlingInstructions’ on each pasteurized egg carton which otherwise advised thepublic on raw egg cartons that eggs should be hard-cooked to avoidillness. The US-FDA in concert with the US-FSIS made a public statementin the late 1990's stating that their target was to eliminate salmonellawithin chicken eggs within ten years and to eliminate there being causefor chicken eggs to continue to be the largest single cause of foodborneillness in the Country. That ten-year deadline as promised by the US-FDAresulted in the 2009 Egg Safety Final Rule. Such was preceded by theUS-FSIS, a division of the USDA, announcing in 2005 thatSe-contamination of chicken eggs had been reduced to be 1 in 277,000from 1 in 20,000 which subsequently was dismissed as being inaccurate bythe legal section of the USDA in their above-referenced report whichreconfirmed that the frequency of salmonella contamination remained tobe 1 egg in 20,000 eggs.

Through the new art to be employed, which includes new protocol thatprovides for the total inactivation of both viral and bacterialcontaminants while at the same time preserving the raw characteristicsof the subject eggs, a new art form for public safety without precedencehas occurred.

Notably, in its evolution the above-referenced current 5-loginactivation of salmonella as found within chicken eggs was specificallyintended to be inclusive of all strains of salmonella and was to besolely employed in liquid egg product which had been adjusted from a10-log level of inactivation in its origin of regulations regardingpasteurization as is confirmed within the contents of the Egg ProductsInspection Act of 1970 which was reduced from a 10-log level ofinactivation of salmonella to 4 logs of Se subsequently. Suchaccommodated the industry's problems encountered with coagulation. Thatreduced level of inactivation more recently raised from 4 logs to 5 logsas measured by Se but still representing only one-half of the original10-log level of inactivation is now claimed by the industry and theagencies of jurisdiction to provide eggs that are safe for consumptiononly if the end product from time of lay of the subject eggs to point ofconsumption are held at temperatures just above freezing excepting forthe timeframe utilized for both collection and prompt pasteurizationi.e. 4 days or less in practice. In the first instance the 5-log levelof Se pasteurization is risky to rely upon for public safety withouthard-cooking but also it has been found that a 5-log level ofinactivation of Se does not inactivate either all strains of salmonellaor viral strains now found to be both present and anticipated to becomeprevalent within chicken eggs. There is ample evidence as discussedherein before that it is common practice to provide chicken eggs to thepublic that are old, mislabeled in grade, stale and repackaged and toinclude high levels of contamination within raw egg cartons as well asco-mingled within liquid egg product. The inadequacies mentioned arecompounded by the risks caused from lack of maintenance of deep chillingof eggs traveling across the country experiencing interruptions tochilling caused by natural disasters, breakdowns and flaws in theprotocol which in the end at best can only provide interrupted deepchilling from farm to table. Further to the above it is common practicewithin the industry to utilize chicken eggs having stale dates of layand known high-count levels of salmonella which are beyond theeffectiveness of pasteurization inactivation of that found within lessthan 10 logs when pasteurized. Notably it has been determined that the‘Best By’ date now at 30 days from date of packaging and not date of layas enabled by the Rule of 2009 now includes known to be highlycontaminated eggs that by regulation are so identified but nonethelessmay be co-mingled into liquid egg product pasteurized at 5 logs using Seas the measure or allowed to be included within in-shell eggs summarilypasteurized in their shells when no chance exists that such eggs whencontaminated either with viruses or salmonella have any statisticalsupport to not be the cause of public illnesses particularly as appliedto the 150.0 million persons currently within the US population who areidentified as high risk groups resulting from compromised immunesystems. Further to the above, and as previously discussed early in thissection, both prior and current practice continues to allow repackagedraw in-shell chicken eggs of stale dates to carry new dates while stillbeing presented to the public as being Grade A or Grade AA. Stillfurther, as previously discussed, each dozen of Grade A or Grade AAcontinues to have available a minimum of two Grade B eggs in each dozenso marks Grade A or Grade AA which obviously creates part of the answerto the obvious question as to why chicken eggs both remain to be thehighest source of foodborne illness and on a pro-rated basis over threedecades has not shown improvement, while at the same time, both theUS-FSIS and the U.S.-F.D.A. have claimed victory for having reducedillnesses caused by the same eggs. The shame of it all includes theavoidable misery inflicted upon the public together with avoidableannual costs which in the span of one year would eliminate the NationalDebt, provide free healthcare for the total population and improve ourmilitary preparedness to protect ourselves from outside dangers alongwith many more benefits which would include higher education andinfrastructure improvements.

Significantly, when either or both liquid egg product or in-shellchicken eggs are pasteurized to 5 logs they currently are qualified tobe labeled as ‘PASTEURIZED’ but most notably are enabled by regulationnot to display the ‘Safe Handling Instructions’ as required on raw eggcartons which provides those with compromised immune systems withappropriate and important notice that eggs must be hard-cooked to avoidillness. Upon further study results it has been determined that viralcontamination requires greater heat inactivation for pasteurization thandoes salmonella. Both pathogens unless totally inactivated require veryprompt and continuous deep chilling from farm to table. Unlike milk,which requires pasteurization with the sole exception of the State ofCalifornia, the effects of pasteurization can be monitored throughtesting before being passed on to the public for consumption. Shell eggscontaminated with either viral or bacterial contaminants cannot betested in any practical form. Equally certainty of deep refrigerationpromptly applied post-lay through consumption which may be weeks apartfrom date of lay cannot be assured to be effective for numerouspractical reasons i.e. equipment breakdowns, storms, public ignorance,power outages, date of collection versus date of lay and numerous otherfactors which include but are not limited to lack of labeling forfoodservice and mislabeling of egg grades.

To aid in clarity the sequence of events influencing the effectivenessof pasteurization caused by changes to the standards established whichwere impacted by failure of protocols employed is recited in part againto provide for both an understanding of what occurred and anunderstanding of the long term negative consequences to public healththat have stemmed from those changes made for improved cost efficienciesof product as opposed to improved benefits to public health.

In 1970, a standard for pasteurization of shell eggs converted intoliquid egg product became needed for public safety for reason thatvarious egg producers were converting substandard eggs either unsold orunsaleable into liquid egg product which was performed under crude andunsanitary conditions. As a result of those conditions and the need forfarmers to appropriately convert selected eggs into liquid egg productto satisfy a market that existed the USDA created regulations andstandards pertaining to the mentioned liquid egg product. Those initialUSDA standards called for a 10-log reduction of salmonella as foundwithin chicken eggs dedicated to be pasteurized and converted intoliquid egg products.

Soon after the new standards were officiated, liquid egg productproducers employing heated tubing to produce pasteurized liquid eggproduct on a commercial scale experienced significant difficulty inachieving a 10-log level of inactivation of salmonella as found withinchicken eggs without coagulating the end product rendering it to beunmarketable.

Without public notice of any nature, the 10-log level of inactivation ofsalmonella was reduced to 4 logs. That status continued to be practicedthrough to 2009 when the US-FDA sponsored Rule required both liquid eggproduct and in-shell chicken eggs to be pasteurized to a minimum loglevel for salmonella inactivation of 5 logs. The requirement for a 5-loglevel of inactivation identifying Se as the targeted strain ofsalmonella resulted from L. John Davidson in 1997 seeking apasteurization requirement for in-shell chicken eggs from the US-FDA ascaused by his success in developing art which enabled pasteurization tooccur without consequential loss of either aesthetics or functionalqualities as compared to a raw in-shell chicken egg. The US-FDA at thattime set the level of pasteurization for in-shell chicken eggs to be 5logs as measured by Se. At that time, Davidson was unaware that liquidegg product was being processed at a 4-log level of inactivation of Se.In or around 2000 Davidson and his resulting company marketedpasteurized in-shell chicken eggs which had achieved a 5-log level ofinactivation of Se. The US-FDA concurrently allowed the subject eggs todisplay the term ‘PASTEURIZED’ while at the same time as the term‘PASTEURIZED’ was allowed to be displayed the requirement to display the‘Safe Handling Instructions’ on pasteurized in-shell egg cartons wasterminated. Also at that time through to the present pasteurization ofchicken eggs to a 5-log level of inactivation of salmonella qualifiedthe USDA shield to be displayed on egg cartons.

It since has been learned that with a certain degree of uncertainty a5-log level of pasteurization performed very promptly post-lay mayinactivate all Se present but not all strains of salmonella which may bepresent since other strains as commonly found within chicken eggs aremore heat-resistant than Se. Concurrently the virus identified as theH3N1 was considered to be as dangerous to public health as was Se.Notably, the USDA required that any chicken flock containing salmonellaor Avian Influenza identified as the H3N1 virus would requiredestruction of the flock, cleansing of the henhouse and destruction ofthe eggs unless pasteurized to a 5-log level as measured by Se. What hadbeen missed for decades at an unknown cost to public health was that the‘H’ series of viruses required still greater log reduction throughpasteurization than does any strain of salmonella as measured by the Sestrain. Notably, since the US-FDA sponsored Rule of 2009 references toviral contamination identified as the H3N1 have been eliminated fromclaims of causing risk when in fact concurrently publications confirmthat the US-FDA together with the US-FSIS were aware that viralcontamination of chicken eggs required greater applications of heat thandid salmonella strains. The mentioned Rule retained the requirement fora 5-log inactivation of salmonella using Se as the measure for allstrains of salmonella albeit the knowledge then existed that a 5-loginactivation of Se unless performed with urgency post-lay for all eggsbeing processed and so labeled even when pasteurized would remain to becontaminated. Notably were pasteurization not to be performed promptlypost-lay the salmonella-contaminated chicken eggs together with thosecontaminated with the H3N1 virus required approximately 10 logs toinactivate viral strains which equated to 12 logs for bacterial strainsas confirmed by various studies which include but are not limited to theUSDA Research Laboratory in Athens, Ga.

To prevent raw in-shell chicken eggs containing salmonella from becominglethal to a consumer when less than hard-cooked, the US-FDA incooperation with the USDA and individual state jurisdictions, have setrequirements for refrigeration of in-shell chicken eggs in order tomaterially reduce the multiplication of salmonella into lethalquantities at time of consumption. As discussed in greater detail hereinbelow, the uncertainties of maintaining deep refrigeration from lay totable which is impacted by interruptions to prompt processing, promptshipping and frequent interruptions to refrigeration, warmertemperatures at point of sale, interruptions to power sources forrefrigeration and the like considered together make reliance uponcontinuous deep refrigeration for public safety to be a false reliance.Such is supported by the presence of salmonella and its high rate ofmultiplication unless under deep and uninterrupted refrigeration. In theabsence of uninterrupted deep refrigeration and within approximately thesame time span as is provided under a ‘Best By’ date the salmonellapresent along with the H3N1 virus if present can multiply into hundredsof millions of cells which materially contribute to why chicken eggshistorically have been confirmed to be the single most cause ofillnesses from a food source regardless of some 25% of the productionbeing pasteurized and the ratio of 1 egg in 20,000 eggs beingcontaminated continues. Those commonly occurring circumstances aremagnified by the exaggerations provided by the false representationsmade to the public under the use of ‘Best By’ dates or their equalswhich lead an unsuspecting public into consuming eggs potentially lethalmost particularly to 45% of the population which are within a high riskcategory of susceptibility to illnesses from bad foods.

The above recited policy and oversight failures together with providingthe public with knowingly false information is compounded by thepreviously described practices of mislabeling product which makesobvious why no progress whatsoever has occurred to improve thecontinuing statistic that chicken eggs whether pasteurized or raw remainto be the leading cause of illness in the United States.

Because of its size and nature of composition the approximate number ofpersons composing what is commonly referenced to be ‘high risk groups’warrants benefit from further details. The number of persons belongingto the mentioned high-risk groups approximates 150.0 million persons orabout 45% of the total population. Those people include all persons of65 years or older, those with heart issues, persons that have contractedAIDS, diabetics, children, post-operative persons and a myriad of othersafflicted with less common illnesses all of which in the end place thecollective group at high risk and the need for costly and continuingcare whether enabled from individual policies, employers or Governmentsubsidies.

Various studies and references within patents issued reconfirm thepresence of salmonella giving cause to illnesses stemming from chickeneggs to be 1 in 20,000. For decades, salmonella-contaminated chickeneggs have been reported to be the single most cause of illnesses in theUnited States. Equally, frequent confirmation exists that a 5-loginactivation of salmonella does not totally inactivate Se since the cellcount level of egg contamination often exceeds the effectiveness of a5-log level of inactivation through pasteurization, nor does a 5-loglevel inactivate all sub-strains of Se. Also a 5-log level ofinactivation of Se does not inactivate all other strains of salmonellaas found within chicken eggs because they are known to require greaterheat than 5-logs for their inactivation. One such confirmation isrecited within this section and is referenced as a patent filed andissued as “Use of CO₂ Cooling in Treatment of Poultry Eggs” as issuedOct. 19, 2005, identifying Kevin Keener as the lead scientist within agroup. When read the referenced patent of Keener et. al. confirms thelevel of inactivation of certain salmonella strains associated withchicken eggs as requiring 9 logs which substantially is consistent withthe initial 10-log requirement set by the USDA in 1970 under itssponsored Egg Products Inspection Act as referenced above. Notably, theoriginal level of inactivation set by USDA was 10-logs and wasnon-specific to it being S. enteriditis. Other studies and reportsdescribed herein throughout reconfirm the requirement of a 10-log levelof inactivation of salmonella as found within chicken eggs as being thelevel of inactivation required to ensure public safety. Such isconfirmed in part through the above referenced findings of Keener et.al. concerning the required level of inactivation of all strains ofsalmonella as may be found within chicken eggs. The rate ofmultiplication of salmonella as found within contaminated chicken eggsmay contain high count levels when being processed or as little as onecell if contaminated at all. The rate of multiplication as indicated bythe USDA Research Laboratory in Athens, Ga., confirms that thecontamination count present at time of lay may double daily post layparticularly when exposed to ambient conditions which occur for a numberof reasons but with noticeable high frequency from farm to table asdiscussed herein before. As an example and as stated earlier in thissection the multiplication of salmonella cells present at time of lay ifas few as 3 cells in a single egg in a matter of 31 days post lay whichmost often precedes the 30 day ‘Best By’ date displayed on the eggcarton will multiply into a salmonella cell count exceeding 1 billioncells without the co-mingling of eggs. Notably, as mentioned earlier,employing Grade B eggs co-mingled with Grade A eggs and repackaging ofstale eggs into new cartons containing new ‘Best By’ dates together withknowingly including two Grade B eggs in dozens marked Grade A or GradeAA further discredits the US-FDA reliance upon a 5-log level ofinactivation of a known count of salmonella as being effective whichwould apply to the whole time frame that the public has been exposed topasteurized liquid egg product which would equate to at least 20 years.For still further understanding of the high public cost from illnessescaused by contaminated chicken eggs consumed by risk groups representing45% of the current population a study authored by the US-CDC confirmsthat “One contaminated egg can contaminate an entire batch of pooledeggs. Everyone who eats eggs from that batch is at risk of illness.” Asfurther reinforcement to the risks to public health recited the USDAOffice of Inspector General in a report dated November 2012 reconfirmsthe implication provided by the recited report from the US-CDC. TheInspector General's report referenced reconfirms that “1 egg in 20,000shell eggs or 1 in 3,600 depending on the egg laying environment wouldhave some level of Se Contamination.”

Recent reports provided by Government agencies take the position that Seas found within the ovaries of a chicken is the significantly mostpredominate source of salmonella contamination of consequence. Suchdefies numerous other studies which confirm that surface-mountedsalmonella to the chicken eggshells whether from prior fecalcontamination since removed or still residually present as may be foundregularly within a carton of eggs at retail makes obvious that thecontamination level of the rinse water employed before packaging is asource of cross-contamination which demonstrates not only itsineffectiveness but also confirms the increased risk to public healthcaused by not only contaminated rinse water but also caused by that samerinse water washing away the natural sealant of the chicken egg whichprotects the otherwise open eggshell pores from environmentalcontamination i.e. dirty wash water as one illustration. Such confirmsthat the continuous use of the same rinse water applied to the eggshellsis the source of broad contamination of the subject eggs. That practiceallows for contaminants to flow into the eggs through the external poresof the eggshells which contradicts the current popular position byagencies of jurisdiction that the vast majority of salmonellacontamination of chicken eggs stems from contaminated chicken ovaries.Still greater protection against recontamination of raw chicken eggs aswell as pasteurized chicken eggs is made available from farm to tablethrough the use of a sealed food-grade egg carton containing anantibacterial agent activated to cleanse the air within the sealedcarton. The preferred choice within the pasteurization protocol selectedand described herein in order to ensure against the results ofincomplete pasteurization and stray contaminants from being enabled tomultiply during the timeframe between pasteurization and consumptionwhich most frequently contains gaps in the continuity of refrigeration.A bio-plastic carton derived from a corn base is the preferred productfor environmental reasons. The bio-plastic carton post disposalself-destructs whereas petroleum-based plastic cartons have become amajor environmental problem due to their enormous quantities ending uppost disposal in landfills which are overcome by their quantities aswell as those same quantities having now proliferated into oceans andlakes causing both aesthetic problems and environmental problemsparticularly to wildlife. Whether so or not the confirmed arrival ofAvian Influenza contaminating both the chicken and its eggs makes mootthe questionable position of Government agencies regarding salmonella inchicken eggs because the level of inactivation of the H5N1 virusrequires a minimum of two (2) additional logs than that of salmonella asthe minimum standard for that group's inactivation according to the USDAresearchers located in Athens, Ga. The new art form reported hereinaccommodates that requirement without consequential deterioration to theaesthetic and functional characteristics to that of a raw chicken egg.

Notably, prior science has acknowledged the presence of viralcontamination of chicken eggs by a strain identified as the H3N1 virus.When found it was treated similarly to that of Se in the protocolemployed i.e. a 4-log inactivation as measured by Se. The USGovernment-authorized protocol employed included the destruction of theflock of producing hens together with the cleansing of equipment and thehenhouses. The eggs laid by the subject chickens whether H3N1- orSe-contaminated were either destroyed or pasteurized to 4 logs asmeasured by Se. That changed under the new Rule of 2009 which alteredthe level of pasteurization of liquid egg product to become 5 logs asopposed to the mentioned 4 logs employing Se as the strain of bacteriaas the base source of measure. No mention within the Rule of 2009regarding the level of inactivation of the H3N1 virus was providedalthough all prior references to liquid egg product pasteurizationtreated the H3N1 virus in the same manner as Se i.e. destruction ofchickens, eggs and cleansing of facilities or subjecting the producedchicken eggs to pasteurization to 4 logs as measured by Se.

The USDA Research Facility in Athens, Ga., for years prior to the US-FDARule of 2009 performed studies on both the progress of the ‘H’ series ofviruses which in particular included the H5N1. Notably the H5N1 asreported by the scientific community is more likely to carry with it thepotential to enable human-to-human transfer than other virus strainsbeing monitored. Currently the H5N1 has been the cause of concern by thescientific community that it is the strain which is most likely to gainthe ability to spread disease between humans which also in the end wouldgive cause to a pandemic. Notably the referenced studies regarding thepublic health threat from the ‘H’ series of viruses also confirm thattheir inactivation requires the equivalency of more or less 40% moreinactivation than does Se as measured in logarithms (logs) for itsinactivation. By interpretation the implication of the new studies wouldbe that the prior acknowledged presence of the H3N1 as found withinchicken eggs previous to the year 2000 was considered to be edible withsafety were the eggs to be pasteurized to a 4-log level of inactivationof Se. That level of inactivation notably was measured by Se which wasnot the most heat-resistant strain of salmonella, nor was salmonellaequally heat-resistant to that of viruses. No statistics exist as towhat portions and at what frequency the public was sickened from theH3N1 virus as found within chicken eggs or chicken egg products.

In summary, Se wrongfully was identified by Government agencies ofjurisdiction as being representative of not only the most virulentstrain but also by implication the most heat-resistant and most commonlyoccurring strain of salmonella as found within chicken eggs. Thoseanalyses of Se were in error. Other known strains of salmonella as foundwithin chicken eggs frequently are acknowledged to contain greaterresistance to heat than does Se. Those more heat resistant strainsinclude but are not limited to Salmonella Senftemberg, Heidelberg,Typhimurium, Newport and Javiana. Such would provide support to aconclusion that a pasteurization level targeted to inactivate Se doesnot inactivate more heat-resistant strains of salmonella which includecertain of those already listed and others not listed whose frequency ofpresence is materially similar and comparable to that of Se. Inconclusion a 5-log level of inactivation of Se on its face neither doesinactivate all Se cells present, nor does it inactivate all salmonellastrains present. Further, a 5-log inactivation of Se does not inactivatethe virus commonly found within chicken eggs identified as the H3N1although historically for decades that virus was treated forinactivation similarly by Government agencies of jurisdiction in itsheat tolerance to Se which was an error potentially of great magnitudeto the health of the consuming public at large. An acknowledgement ofthe magnitude of the issue raised concerning the H3N1 being treated ashaving the same tolerance to heat as that of Se which in itself wasunderstated is now found to be confirmed through the engagement of adivision of a French firm known as Sanofi Pasteur to find a vaccine forAvian Influenza whose source is the same virus series as the H3N1.Reportedly the US Government executed a contract amounting to $150.0million to develop a vaccine for protection against the ‘H’ series ofviruses anticipated to cause a pandemic resulting from viruses givingcause to illnesses which are generally referred to as Avian Influenza.

The above-cited ineffectiveness of a 5-log level of inactivation ofsalmonella strains was set as the standard for co-mingled chicken eggsinto liquid egg product which included the specific salmonella strainidentified as Se whose genesis is alleged to predominantly stem from asource internal to the eggs and not external to the eggs or theirshells. Prior art determined that Se-contamination was passed from theovaries of the afflicted chickens into the embryos of the eggs andremained there through time of lay. Current studies confirm that Se andother strains of salmonella contaminate chicken eggs through externalsources as well. Those external sources are aided in their frequency ofcontamination through the manner of washing the eggshells improperlybefore grading and packaging. Further external contamination occurs whenpasteurization of in-shell chicken eggs creates a mass of airbornecontaminants resulting from salmonella cells internal to the eggs beingforced into the environment of the air through the eggshell pores as aresult of the heat applied during pasteurization causing the internalegg to expand and to force salmonella cells surviving the application ofheat to exit the eggs and to relocate within the air surrounding thepasteurization medium employed even when a negative atmosphere isemployed. Notably an environment containing a negative atmosphere aspreviously employed even if materially improved would be ineffective torely upon to dismiss and to disburse the quantity of salmonella cellshaving become airborne as has been confirmed through prior experience.What actually occurred in production was that the concurrent internalcontraction of thousands of chicken eggs beginning to cool postpasteurization created a current of air which carried with it the returnof the airborne salmonella cells which had survived the heat ofpasteurization by escaping through the chicken eggshell pores into theatmosphere surrounding the processing. Post pasteurization thecollection of the subject eggs began concurrent contraction which gavecause to the creation of an air current flowing into the eggs throughthe exposed shell pores which had lost their natural sealant from therinse water previously employed. The loss of the natural sealant whichprotected the subject eggs from external contamination provided for amultitude of open shell pores on each of the subject eggs. Thecombination of the internal contraction of the eggs while ambient orinduced chilling occurred post pasteurization together with havingcreated avenues for contaminate reentry through the exposed eggshellpores provided an opportunity not only to nullify the benefits ofpasteurization of contaminated eggs which according to Governmentstatistics is 1 egg in 20,000 eggs but instead the described phenomenonexposed all of the eggs to contamination through the current createdfrom the concentration of pasteurized eggs effectively sucking incontaminated air through their exposed eggshell pores resulting from thedescribed current created from their en masse cooling and contraction.The new art described herein below successfully eliminates the describedrisks of recontamination while achieving even greater log levels ofinactivation which clinically can be claimed to provide totalinactivation and importantly preserves the raw characteristics andnutritional values of the subject in-shell chicken eggs. Similar sourcesof contamination occur within liquid egg product. In the case of liquidegg product under the Rule of 2009 it specifically enables liquid eggproduct to utilize known to be and so identified to be already highlycontaminated eggs to be co-mingled and to be labeled as ‘PASTEURIZED’after receiving a 5-log inactivation employing Se as the measure.Statistics flowing from USDA studies confirm that a moderatelycontaminated chicken egg containing as few as 3 Se cells at time of laycan multiply into a salmonella cell count exceeding 1 billion cells in amatter of 31 days as has been discussed herein above. As will bediscussed herein later numerous violations concerning the age andcondition of chicken eggs as packaged for food service and retailcommonly occur with full knowledge by both industry and agencies ofjurisdiction. Such includes co-mingling of grades without disclosure andrepacking stale eggs to carry more current dates for use. Also includedis disclosure of rinsing protocols which in lieu of cleansing eggshellsspread contamination. With some 150.0 million persons officiallyidentified as being at high risk of illness the inclusion of whatobviously are highly dangerous contaminated eggs pasteurized to aninadequate level to provide safety is a matter warranting immediateattention particularly for both the risk groups as compounded by the newand magnified threat of still more dangerous illnesses derived fromviruses which remain to be a major threat to public health whencontained within chicken eggs over that of salmonella. That viral threatwill be magnified were a strain enabling human-to-human transfer tooccur. Reports as recently as in 2015 confirm that various virus strainsare evolving and locating themselves around the globe giving cause fortens of millions of chickens to be destroyed while concurrently selectedcases of human-to-human transfer also have been recorded.

The USDA Research Laboratory located in Athens, Ga., confirms that a 6-to 7-log inactivation of Se equates to a 5-log inactivation of virusesas contained within the ‘H’ series. That statistic only applies to theratio of heat tolerance between bacteria and viruses as is or may becomefound within chicken eggs. That ratio has nothing to do with the countas measured in logarithms (logs) regarding levels needed forinactivation i.e. total inactivation. Therefore, for at least 25 yearsthe H3N1 virus mistakenly has been treated as having the same 5-loglevel of inactivation through pasteurization as that of the strain ofsalmonella identified as Se. Further, as stated, the success ofinactivation of salmonella in general has been materially overstated asa result of employing a 5-log inactivation to be effective against allstrains of salmonella at all levels of concentration as may be foundwithin a known to be highly contaminated in-shell chicken egg or withinknown to be highly contaminated liquid egg products. Of importance andof material significance the same USDA Research Laboratory identifiedother strains of salmonella common to chicken eggs as being moreheat-resistant than Se which when considered from a public safetyvantage point those strains would require a 1-log or greater level ofpasteurization to provide the equivalency of inactivation gained fromthe protocol using Se as the model strain of bacteria targeted and to beinactivated through a protocol employing 5-logs as the target for Se.Simultaneously recent science reconfirms the findings of prior sciencethat all strains salmonella as found within chicken eggs are inactivatedat approximately 10 logs. Such contradicts what has been practiced fordecades regarding salmonella inactivation when found within chickeneggs. The practice employed for decades included an inactivation ofsalmonella as represented by Se which called for an inactivation levelof 4 logs initially and more recently 5 logs as found within the US-FDARule of 2009. Curiously the US-FSIS in 2005 alleged that a 6-log levelof inactivation of salmonella as found within chicken eggs would beappropriate for public safety when used as the level of inactivation ofsalmonella.

The above recitation concerning inadequate pasteurization and associatedrisks raise issues whose results clearly place the public health at riskfrom the consequences of consuming contaminated chicken eggs when lessthan hard-cooked. A restatement of selected points raised herein beforeis offered to make clear the inadequacies of current pasteurization asproviding public safety for a variety of health risks which agencyoversights have discounted or concluded not to be significant enough toeither repair or to condemn from use for the public good. Such includes:

1. In the first instance the inadequacies of a 5-log Se level ofpasteurization whether for in-shell chicken eggs or liquid egg productplaces the public at risk of consuming egg dishes which are contaminatedas caused by inadequate pasteurization unless hard-cooked.

2. The Government has failed to protect egg consumers by allowing thediscontinuation of the public warning entitled ‘Safe HandlingInstructions’ on shell egg cartons if the subject eggs had beenpasteurized to a 5-log level of Se inactivation. Notably the Governmentcontinuously has been aware since the inception of pasteurization asapplied first to liquid egg product that a 5-log level of inactivationof all strains of salmonella when present within a contaminated chickenegg is inadequate to provide the public with safety from food poisoningunless the subject eggs have been hard-cooked. That knowing anddeliberate elimination of the mentioned ‘Safe Handling Instructions’from in-shell egg cartons pasteurized to a 5-log level of inactivationof salmonella as measured by Se created a public risk caused by relianceupon pasteurization being safe when actually the level of pasteurizationat 5-logs was unsafe. The replacement of the ‘Safe HandlingInstructions’ with the term ‘PASTEURIZED’ provided the public with falseconfidence in the safety of the product. The presence of the USDA shieldalong with the term ‘PASTEURIZED’ contributed to the falsely placedconfidence in the qualities of safety to be found within the chickeneggs being provided whether pasteurized to 5-logs or raw as found withinin-shell eggs so marked as Grade A or Grade AA. Public confidence in theGrade mark together with the USDA Shield displayed likely stemmed fromtheir experiences with milk within which when the term ‘PASTEURIZED’ wasemployed the public was provided comfort that through long experiencethe product was safe for consumption. That nature of misinformation wasreinforced further by the conspicuous absence of the otherwisecontinuing presence on raw egg cartons of the message contained withinthe referenced ‘Safe Handling Instructions’.

3. With the advent of Avian Influenza as found within chicken eggstogether with its forecasted potential ability to transfer illness fromhuman to human, which is reported to include a 40% mortality rate, thecertainty of egg pasteurization being effective becomes critical to theconsuming public.

4. In the absence of total inactivation of targeted pathogens throughpasteurization of in-shell chicken eggs, the use of protocols to improvepublic safety have been employed to reduce the quantity of illnesses ascaused by salmonella contaminated chicken eggs. One of those protocolsincludes a mandate which contains a requirement that prompt and deeprefrigeration of in-shell chicken eggs be employed from farm to table inorder to reduce the acknowledged risk of illnesses from increased levelsof salmonella contamination of eggs unless hard-cooked. On its face thatstatement confirms that a 5-log pasteurization of salmonellacontaminated chicken eggs is unreliable to provide the public withsafety from illnesses stemming from salmonella contaminated chicken eggsemploying 5-logs in combination with chilling. Uninterrupted deeprefrigeration from farm to table likely is rare rather than reliable.

5. The inadequacies of a 5-log inactivation of salmonella are furthercompounded by the US-FDA sponsored Rule of 2009 which specificallyallowed for known to be highly salmonella contaminated chicken eggs tobe included within liquid egg product and separately enabled theinclusion of similarly contaminated eggs to be provided to the public aspasteurized in-shell eggs which in each case enabled the survival ofsalmonella post having received a 5-log level of inactivation which wasand remains to be the minimum allowed level of pasteurization asauthorized by the US-FDA.

Notably no known science exists which supports a claim that known to behighly salmonella contaminated chicken eggs can have their salmonellacount inactivated through use of a 5-log protocol of inactivationemploying pasteurization targeting Se.

The described inadequacy of a 5-log level of inactivation of asalmonella contaminated chicken egg which allowably includes known to behighly contaminated eggs is further magnified by co-mingling withinin-shell egg cartons carrying Grade A or Grade AA marks when actuallyunder current regulations such may include a ratio of up to two (2) eggsper dozen more or less as applied to in-shell eggs which in fact areGrade B. As commonly known by both Government and industry Grade B eggsfrequently contain count levels of salmonella which not only exceed5-logs for their inactivation through pasteurization but also likelyrequire up to 10 logs for that inactivation.

In summary to the above, the reduction by Government agencies fromemploying the original 10-log inactivation for salmonella to that of a5-log level of inactivation as applied to salmonella in all strains asmay be present within chicken eggs requires aid to achieve a resultwhich makes the subject eggs safe for public consumption unlesshard-cooked. The new art discussed herein provides for a protocol forpasteurization of chicken eggs which enables the achievement of totalinactivation of the targeted pathogen without consequential forfeitingof either raw characteristics or nutritional benefits. That protocolessentially provides for the achievement of salmonella inactivationinitially identified and set to be the standard for public safety in theearly 1990's by the USDA.

6. Notably, all shell egg cartons carrying pasteurized shell eggs areallowed not to carry ‘Safe Handling Instructions’ which cautioned thepublic when displayed on raw egg cartons that eggs when consumed lessthan hard-cooked may cause illnesses.

Although the ‘Safe Handling Instructions’ have been displayed onin-shell egg cartons for more than approximately 15 years excepting eggcartons containing in-shell eggs pasteurized to a 5-log level ofinactivation for salmonella as measured by Se the frequency of 1 egg in20,000 eggs being salmonella contaminated has not reduced and with thegrowth in consumption the number of contaminated eggs together with thenumber of illnesses have increased proportionately and at the samefrequency as if no improvement through either pasteurization or HACCPever has occurred. Notably one item only of pertinency has survived. Thecost per illness initially carried at $20,000. over the past two decadeshas resisted inflation and remains to be at $20,000. per illness.

Further to the above, in a recent report dated November 2012, the USDAthrough its Inspector General, reconfirmed that the rate of salmonellacontamination of chicken eggs remains to be 1 egg in 20,000 eggs.Notably and of possibly greater consequence the quantity of chicken eggsproduced within the United States without diversion to liquid eggproduct has risen over the past dozen years from 3 billion dozenin-shell chicken eggs per annum to 5.5 billion dozen. That increase, byitself, nearly doubles the in-fact frequency of illnesses caused bysalmonella. Still more notably the same referenced report from the USDAtogether with a report from another responsible agency identified asNERO not only confirms the frequency of illnesses but reconfirms variouspractices performed within the egg industry as known by Governmentagencies that on their face are unethical and approach criminality inpractice as related to knowingly delivering unhealthy product to thepublic and knowingly mislabeling that same product which in the endundeniably sickens and kills an unsuspecting public. The irregularitiesreferenced include but are not limited to repacking of stale eggs,falsely labeling the grade of eggs, using the USDA shield implyinginspection and safety when frequently such has not occurred to mentiononly a few of numerous long-standing and continuing violations of thepublic trust.

In contradiction to the confirmed recitations provided above concerningthe questionable practices recited within the egg industry and theirknowledge to agencies of jurisdiction, certain agencies continue toclaim dramatic progress has been made in the reduction of illnessescaused from contaminated chicken eggs. Those announced reductionscoincide with the self-imposed deadlines for material improvements inthe reduction of illnesses from chicken eggs which traditionally havebeen and continue to be the highest source of illnesses as found withinthe food group. New reports based upon old studies reconfirmed thefrequency of contaminations was altered to support new conclusions tosatisfy a self-imposed deadline to reduce the inordinate quantity ofillnesses as caused by salmonella contained within chicken eggs. Thatmisinformation is contradicted by a report authored by the United StatesDepartment of Agriculture Office of Inspector General. The referencedreport of recent date reconfirms the frequency of salmonellacontamination of chicken eggs to be 1 egg in 20,000 eggs. Thatreconfirmation of the frequency of contamination is material because theconsumption of in-shell chicken eggs per annum within the United Statesin or around the year 2000 approximated 3 billion dozen which accordingto current statistics has increased to be nearly two-fold i.e. 5.5billion dozen per annum as of 2014 production. Of particular added notecurrent reports confirm that not only do high risk persons carry withthem a greater risk of illness from contaminated food but also eachillness occurring within the mentioned group includes a costsignificantly greater on average than those costs experienced by personsof ordinary health.

Risk groups have come to rely upon the clearly implied safety providedby pasteurization enabling consumption of eggs when less thanhard-cooked and presumed to carry no risk of illness as is enabledthrough thorough pasteurization. Such reliance upon pasteurization hasbeen further enhanced by egg cartons, whether liquid or in-shell,qualifying the product to display the term ‘PASTEURIZED’ and not todisplay the ‘Safe Handling Instructions’ as required to be displayed onall unpasteurized egg cartons. Those Instructions warn the public thatunless eggs are hard cooked they may cause illness particularly to themore susceptible members of the mentioned risk groups. Through 2015those Instructions have been continued to be carried although it haslong since been known that reliance upon prompt, continuous andun-interrupted deep refrigeration from farm to table is not onlyimpossible in practice but potentially lethal to the consumer who has noreason to be aware of the inadequacies and the limitations of thepasteurization protocol employed. Notably deep refrigeration never hasprovided any form of inactivation of the strains of salmonella that notonly may be present but also may be impacted by flaws in thedistribution system which allow for lethal multiplication of salmonellaand other pathogens when present to occur. In the absence of anineffective level of inactivation of targeted pathogens throughpasteurization as combined with false reliance upon interruptible deepchilling an inordinate multiplication of pathogens present will continueto occur. In the end the cumulative multiplication of pathogensoccurring benefiting from multiple interruptions of deep chilling fromfarm to table provides an unsuspecting consumer with contaminated eggswhich historically reconfirms the long-standing statistic thatcontaminated chicken eggs are the leading cause of foodborne illnessesamongst all food groups in the United States as is reconfirmed bypublished statistics each year for at least the past four decades.

Notably, as discussed, the inventiveness contained within the new artdeveloped enables total inactivation of all strains of salmonella as maybe found within chicken eggs. Further, those new discoveries whenimplemented enable the faulty protocols described hereinabove to be bothreplaced and allows for the end product to be cured of deficiencies.Such will provide for the public safety from salmonella-contaminatedchicken eggs it deserves. Separately and notably the mentioned newdiscoveries not only provide a unique ability to eliminate salmonella asfound within chicken eggs while retaining the nutritional benefits ofthe subject eggs together with the preservation of their rawcharacteristics but also the same new art can provide equivalent resultsto chicken eggs contaminated by strains of viruses which in the endproduces Avian Influenza.

New discoveries described herein now protect against new and far moreserious threats provided by viral contamination over those ofsalmonella. The new art resolves the need for greater levels ofinactivation of all strains of salmonella as found within chicken eggsas opposed to prior art which targeted salmonella as mistakenlyrepresented by Se and mistakenly determined that the employment of a5-log protocol to inactivate Se would be effective in inactivating allstrains and levels of salmonella contamination which may be presentwithin a contaminated chicken egg. Separate from the mentioned faultytargeting of 5 logs for the successful inactivation of Se it was learnedthat the recited level of inactivation of Se was both inadequate toinactivate Se due to excessive cell count levels which may be present attime of pasteurization as further compounded by Se not being the mostheat-resistant strain of salmonella as found within chicken eggs. Theproblem of eliminating salmonella in chicken eggs as a public healthrisk was compounded further by reliance upon dangerously flawedprotocols. The mentioned flawed protocols stemmed from the reliance uponvery prompt chilling of the subject eggs occurring at the farm level andcontinuing through table without consequential interruptions.

The above-described protocol was and continues to be impossible toperform for a variety of reasons. It misleads the public into believingthat the eggs are fresh when that assumption is based uponmisinformation.

As USDA Research Laboratory studies confirm the level of salmonellacontamination when present before application of deep chilling in amatter of five days or so multiply into a few hundred cells. Ifinterrupted from continuous and deep chilling while being shippedthroughout the United States as such applies to protocol fordistribution occurring from farm to table each egg individually ifcontaminated or pooled together as in liquid egg product will result inthe salmonella cells present multiplying into quantities readilyapproaching or exceeding 1 billion salmonella cells in a matter of 31days. The above recitation of risks materially are compounded bypractices more fully discussed herein elsewhere within this sectionwhich allow for agencies of jurisdiction employing oversight toprocessing facilities to allow stale or returned eggs usually carryingwith them materially interrupted refrigeration to be repackaged into newcartons contain a new ‘Best By’ date. Notably, as also discussedelsewhere above, those repackaged eggs already may contain on averagetwo (2) eggs or slightly more per dozen being Grade B eggs although thecarton is allowed to carry marks indicating either Grade A or Grade AAwhich provide no indication that approximately 18% of its contents areofficially allowed to be Grade B eggs which are capable of causing bothillness or deaths to unsuspecting recipients who rely upon the markingsof the grade of the eggs, the ‘Best By’ dates, the grade indicated andthe integrity of the USDA Shield. Still more notably all of therepackaged eggs if containing salmonella to begin with would be free togain a level of salmonella contamination which would exceed the abilityof a 5-log level of inactivation as currently allowed under thementioned Rule of 2009 to be termed as ‘PASTEURIZED’ At the least duringthe timeframe of lay to a second round of packaging containing a future‘Best By’ date the increased amount of bacterial multiplication createsnew and still higher risks of illnesses that are passed onto anunsuspecting public for consumption including particularly those personsknown to be within risk groups as identified by the Government itself toconsist of about 45% of the population which equates to 150.0 millionpersons. In further support of the risks to public health outlined abovethere are added risks which in part stem from weather patterns anddistribution systems combined with flawed statistics treating collected,stored, stacked and refrigerated eggs without due consideration tomultiple interruptions and lag times impacting upon the neededcontinuous deep refrigeration occurring from farm to table. Theabove-described reliance upon uninterrupted deep refrigeration from farmto table not only is impossible but also is knowingly misleading forreason that in the first instance the public is not aware that the‘sell-by’ date is based upon the packing date which has nothing to dowith the date of lay or the age of the eggs when collected or stored.The public is further misled by having no knowledge as to whether thesubject eggs were continuously and deeply refrigerated or, moresignificantly, were not. Further, the public generally is unaware of the‘Safe Handling Instructions’ which deliberately contains a selectedprint size which avoids notice.

Further to the inadequacies recited above, the USDA official Shield isemployed by the industry to provide the public with a false sense ofsecurity which is not the intended purpose of the Shield's presence. Allof the above recited risks to the public health and its wellbeing areresolvable under the new art through its areas of inventiveness whichprovide for total and permanent inactivation of bacterial contaminantsas well as viral contaminants now known to be contaminating chicken eggsthrough the environment of the henhouse itself, through the water thechicken drinks along with the food it eats and through the water inwhich the egg is rinsed during processing together with thecontamination invading the eggs externally from its compromisedcleanliness as created from the pollution from and within the henhouseincluding the air within and ending with the frequency of employingcontaminated rinse water prior to grading and packaging.

The new art described and disclosed herein contains new and uniqueprotocols which result in the ability to materially expand when neededthe pasteurization protocol employed to achieve higher log levels ofdestruction of targeted pathogens which include not only bacteria butalso viral contaminants both existing currently and as forecasted byagencies of responsibility to give cause for a pandemic resulting fromviral sources. The described level of inactivation of targeted pathogensto be achieved is complete.

In order to accommodate the inactivation of higher levels of viruses asforecasted to become present within chicken eggs, the new art asdescribed in greater detail elsewhere herein employs both redundancy ofthe intermittent application of heat along with an intermittentapplication of induced chilling which when programmed in theirapplications cumulatively provide for levels of pasteurization of allparticles of an egg that satisfy the need to inactivate viruses whichrequire greater heat inactivation as measured in applicable logs thanprior art was able to accomplish through a 5-log level of inactivationof salmonella bacteria. Of equal importance, the art described preservesall of the nutritional benefits contained within the subject eggswithout forfeiture of the eggs' raw characteristics. For further clarityand emphasis the novel elements described and employed within the newart as more completely detailed herein below protects all portions ofthe egg and most particularly the outer albumen from losing raw eggaesthetic and functional characteristics post-exposure to the new andunique higher levels of pasteurization which in the end providecertainty that both viral and salmonella contaminants have beeninactivated totally which by definition carries with it the uniquefeature of totality.

Of notable and significant discovery, the benefits from the increasedheat sensitivity of the outer albumen are enhanced by the location ofthe outer albumen being nearest to the heat source. The transfer of heatfrom external sources through the outer albumen into the inner body ofthe subject egg in order to avoid heat damage through coagulation of theouter albumen requires separate treatment. Under the new inventivenessdescribed herein the separate treatment of the outer albumen forprotection against coagulation is achieved by controlling the heatsource through intermittent cooling whether induced or through naturalambient cooling only after equilibrium has been reached between theinitial pasteurization medium temperature setting and the internaltemperature of the egg in all of its separate elements has occurred. Thedescribed intermittent cooling is performed in a manner that takesadvantage of the more rapid rate of heat gain and heat loss of the outeralbumen. Through that described outer albumen temperature control, asimilar protocol using the same principles discovered can be varied toaccommodate necessary modifications for the other elements of the eggswhich through their varying densities require different exposures toheat or its absence as related to the outer albumen from which thevariables of heat exposures and denials as contained within thediffering elements of the subject eggs are converted into the formula tobe employed. Notably under the new art those elements never are allowedto reduce their respective temperatures to be below the minimumtemperature for pasteurization of 128° F. excepting for the outeralbumen which benefits from avoiding coagulation by intermittenttemperature reductions below 128° F., as per the protocol employedwithin the new art. For better understanding, such is accomplished bythe recognition of the proximity of the outer and thinner albumen beingclosest to the external heat source being applied which includes thedenial of heat to the outer albumen from that same source. The preferredmanagement of the denial of heat includes induced chilling of thesubject eggs through reducing the temperature of the water employed inany form which may include just air containing either a normal range ofwater content or an increased water content contacting the eggshellswhich provides for both more exact log management and lower overallprocessing time which converts into lower cost of product. The heatapplication source preferred is the use of a water shower which withinits embodiment provides flexibility which can be altered into a mist oreven a fine spray of water containing in all options a food-gradeantibacterial agent or even air similarly purified and containingminimal moisture all of which aid in the inactivation of pathogens, thespeedier and improved precision of temperature control and the morethorough exposure of all elements of the eggshells to the temperaturesprogrammed. The water itself whether in the form of a mist or a denserspray or even to the extent as found within air for health safetyconcerns is warmer than the internal temperature of the subject eggswhich are subjected to continuous purification through applications ofheat which carry a food-grade antibacterial agent that is continuouslymonitored and supplied. That protocol provides for expansion of theinternal eggs through the controlled intermittent application of heatwhich blocks the intrusion of pathogens attempting entry through theexposed eggshell pores while at the same time the application of theheat inactivates pathogens previously residing within the contents ofthe eggshell. Survivors to the heat being applied to the internal eggare forced to exit through the eggshell pores due to the expansion ofthe internal egg. As the pathogens escape through the eggshell pores ascaused by the expansion of the internal egg contents reacting to theheat being applied the pathogens become exposed to the externalapplication of heat through the selected medium being employed carryingwith it a food-grade antibacterial agent which enables the totalinactivation of the targeted pathogens to occur.

Under the new protocol employed the outer albumen uniquely is allowed tofluctuate in its temperature to prevent against heat damage as enabledby programmed changes of the temperatures employed through intermittentapplications of heat or its denial which in the end may be provided inthe form of spray or even air whether moisturized or otherwise appliedto the exposed eggshells. All of the above is performed while thesubject eggs are within an environment which is safe from residualcontamination from the pasteurization protocol being employed and safefrom environmental contamination which has been the plague of prior art.The protocol ingredients are formulated in a manner which never allowsfor the pasteurization of the inner albumen, the vitelline membrane andthe yolk to not receive the level of heat i.e. 128° F. or greater asapplied intermittently to the eggshells from the selected source whichincludes sanitized water as the preferred source in the form of a sprayor a mist along with an option to employ sanitized air together withsupport from such cleansers already included within the protocoldescribed containing ultraviolet as one example of an additional agentsupporting each of the mentioned options employed for heat transfer andits denial in accordance with the new time and temperature protocolparameters described as enabling total inactivation of the targetedpathogens. The formulated application of heat and its denial through themedium selected allows for both the absence of heat and induced chillingto occur at pre-selected intervals and equally allows for theapplication of heat also at pre-selected intervals. In principle thecontrolled application of heat and its denial throughout the uniquelysecured environment of the medium employing the application selected toapply such to the exposed chicken eggshells enables the manipulation ofthe durations of exposure to the subject temperatures employed to eachelement whose properties contained in their composition dictate the rateof heat gain as well as the rate of heat loss. The outer albumen asbeing the first element to react to heat and its absence becomes thedominant element dictating the ingredients of a new formula whichemploys a unique program pre-prepared for each batch of eggs addressingtheir specific and individual characteristics that through adjustmentsenable the achievement of targeted logs to a unique level ofinactivation. Through the mentioned adjustment to the referenced formulafor pasteurization of the subject in-shell chicken eggs a totalinactivation of targeted pathogens is available through the specificformula created to satisfy the targeted total inactivation of pathogenswhile preserving the raw characteristics of the subject eggs. Such isaccomplished through the application of a formulated intermittentapplication of heat and its denial which in the end provides for notonly total inactivation of targeted pathogens but also preserves the rawcharacteristics of the chicken egg by protecting the outer albumen fromheat damage through the inclusion of pre-planned intervals ofintermittent cooling that reduces only the temperature of the outeralbumen to fall below 128° F. but allows for the continuation ofpasteurization to progress for each of the other elements at varyingrates reflective of their differing compositions enabling theirtemperatures to remain above 128° F. The resulting total inactivation oftargeted pathogens is accomplished by providing heat and its denialintermittently to the subject eggs on a customized basis which ispre-formulated. The duration of those applications are egg specific asto their characteristics i.e. size, targeted logs, water content andother factors as known to the art. In the end the intermittentapplication of heat and its denial protects the outer albumen fromcoagulation and allows for each of the differing internal elements toachieve approximately the same log reduction of targeted pathogens atapproximately the same time lengths of exposures to the temperaturesapplied while preserving the raw characteristics of each element asenabled by the flexibilities provided by each element as measured bytheir densities and rates of heat transfer which by nature have beenarranged within the egg in an order of both location and densities ofsubstance that enables the application of heat applied to or denied fromthe eggshell to be transferred to the differing elements within the eggin a manner which in the end provides for a level of inactivation oftargeted pathogens that has flexibility enough between elements toenable total inactivation and to retain in each case the basiccharacteristics of a raw chicken egg. Hence, the outer albumen and itsunique characteristics both dominate and enable the protocol employedunder the new art discovered and formulated. These new discoveries whenformulated into a pre-programmed protocol addressing specificcharacteristics of the subject eggs by groupings enables the ability toperform pasteurization of in-shell chicken eggs absent of any risk ofillness when consumed by the public within food servings of all recipescharacteristic of chicken eggs being an ingredient.

A sense of urgency exists to create a new and materially higher level ofpasteurization without causing damage to the subject eggs over thatachieved by prior art. The mentioned urgency is confirmed by a need fora level of pasteurization of chicken eggs to counteract the riskscreated as described within new reports published during 2014 confirmingthat still newer virus mutations involving birds have occurred inGermany, The Netherlands and Southeast Asia as well as China includingbut not limited to the H7N9 virus along with other strains of equalnotability which in some cases stem from the H5N1 virus that may becomeable to successfully achieve human-to-human transfer and in still othercases that risk is potentially available from other viruses throughseparate generation or mutations.

Of significant relevance to the above-described threat to public healthin June 2013 the United States news reports confirmed that the H7N7virus had been found within chickens marketed by Tyson Foods who is aleading supplier of edible chicken to the United States public. Furtherto the above on May 2, 2014, news releases within the United Statesreported that a death had occurred from a virus strain similar to thestrain of the above-mentioned virus previously found to be presentwithin chicken meat produced by Tyson Foods. Read together the foreignreports of virus strains and the same strains as reported in Europetogether with a deviation of those mentioned strains now occurringwithin chicken meat in the United States reasonably give cause forconcern that WHO correctly has forecasted a pandemic as derived fromAvian Influenza in the near term as needing only time to blossom.

Of even greater significance to the urgent need to provide the publicwith a safe egg as a needed food source clearly is illustrated andconfirmed by a pandemic already reported to have occurred within theUnited States between April 2009 and April 2010. Although the specificsconcerning the viral source never have been identified clearly the scopeof the pandemic speaks for itself as does the lack of warning before itsarrival. Within a span of 12 months the mentioned pandemic inflectedupon the United States public 60 million illnesses and was reported tohave caused 12,000 deaths.

The new inventiveness claimed herein does not intend to be the solesolution to solve a pandemic. However, the new inventiveness if employedprior to the pandemic occurring will provide not only safety from eggscontributing to the quantity of people initially stricken but also willprovide for the preservation of a basic and needed food source which issafe for consumption when safe food would be in short supply.

The above-referenced H5N1 virus together with derivatives stemming fromthat virus or viruses which may not be directly related each to theother but already reported to exist and representing separate risks tothe public on their own collectively create a recognized andscientifically-confirmed forecast that a real and present threat of apandemic is in the making. The pandemic materially is enabled by thecurrent viral strains referenced together with their direct or indirectderivatives having the ability to enable human-to-human transfer ofillness.

Notably and with consistency to the forecasts of a pandemic occurring inthe near term the above-described events not only confirmed thoseforecast but also reinforced by the somewhat veiled newscast occurringin May 2015 which confirmed that 50 million laying chickens had beendestroyed because the flocks were infected with Avian Influenza.

According to scientists at the USDA Research Laboratory were Se to beinactivated through the application of heat by 2 logs greater than thetargeted log reduction of the H5N1 virus that ratio can be employed inprotocols targeting the destruction of the H5N1 virus as may requireadjustment caused by mutations and defense mechanisms created by thevirus which commonly occur in the evolution of viruses. In that regardthe new art enabling higher and ultimate levels of inactivation of bothviral and salmonella strains as found within chicken eggs has beenadjusted in its capacity to provide for total inactivation of the knownto be greater heat resistance of viral strains over salmonella strainsas now enabled by and through the employment of the new and uniqueprotocol claimed herein which accomplishes the mentioned inactivationwhile maintaining the raw characteristics of the chicken egg.

Further considerations to utilizing new protocols to destroy all threatsfrom both viral or bacterial contamination as found within chicken eggsthrough employing one rigid formula for all circumstances creates a riskof failure along with a public health risk when such practice ofemploying a 5-log protocol of destruction of salmonella bacteria assponsored by the US-FDA in 2009 is used.

Notably and materially in addition to the above-described inadequaciesof a 5-log inactivation of salmonella the US-FDA under its Rule of 2009allowed for the inclusion of highly contaminated eggs within whichsalmonella counts exceeded the ability of a 5-log level of inactivationof Se through pasteurization to be effective. Notably those eggsresulting from the above-described inadequate pasteurization werequalified to display the term ‘PASTEURIZED’, display the USDA shield andto discontinue the display of ‘Safe Handling Instructions’ which was anotice to the public concerning the risks carried within chicken eggsunless consumed when hard-cooked.

Notably and with materiality to the above recitation regardingviolations of the public trust through faulty labeling of unsafeproducts such is further supported by the specific allowance andpractice enabled by the US-FDA sponsored Rule of 2009 within which theinclusion of known to be highly salmonella-contaminated chicken eggsso-marked are allowed to be included in liquid egg product resultingfrom co-mingled eggs which include the so mentioned, highly contaminatedeggs. Further to the above current practice allows for repackaging of acarton of eggs containing a stale date to one of a current date whichcarries with it a new ‘Best By’ date which displays ‘Safe HandlingInstructions’ on the carton. Considered together the above-describedabuses to the public trust represent Government-sanctioned fraud whetherinadvertently or otherwise. Further, as discussed herein above, in areport by NERO whose title carries the credentials of that organizationwithin its formal name i.e. National Egg Regulatory Officials theshortcomings of egg grading and labeling are discussed. Those recitedshortcomings include but are not limited to the long-standing use oflabeling Grade A and Grade AA eggs with new ‘Best By’ or equivalentlanguage dates when in fact the eggs may have been returned eggs whichhad not sold at retail and were relabeled and repackaged to carry a new‘Best By’ date in obvious fraud to the consuming public. Significantly,persons representing 45% of the population i.e. 150 million areidentified as being members of groups with compromised immune systems.Further to the above the stale eggs which allowably included highlycontaminated eggs from the original time of packaging likely wouldrequire a 10-log pasteurization level for inactivation of salmonella ifconverted into liquid egg product. As previously discussed if notconverted into liquid egg product NERO also reconfirmed that the chickeneggs packaged within Grade A and Grade AA cartons under common practiceallowed up to 18% of Grade B eggs to be included without causing changeof grade labeling from the Grade A and Grade AA categories. NotablyGrade B eggs even if pasteurized to 5 logs carry with them little or nohope of successful salmonella inactivation due to the inherent risk ofthose eggs having an age and condition stemming from an environmentenabling levels of salmonella contamination requiring far in excess of 5logs as measured by Se for total inactivation as intended or representedby Government agencies of jurisdiction. Such results in millions of Secells being present by the time of consumption regardless of levels ofdeep chilling employed as an option but which in actual practice isineffective in providing reliable protection unless hard-cooked orpasteurized to a materially higher log level reduction as is providedunder new art described herein which unto itself achieves totalinactivation which eliminates the risks from failures of imperfectfarm-to-table deep refrigeration along with the risks recited hereinbefore regarding both mishandling of products and mislabeling ofproducts to an unsuspecting consumer recipient even when current levelsof pasteurization of chicken eggs are employed.

The new inventiveness claimed herein is broad enough in its scope andabilities to be utilized in a protocol which enables the level ofdestruction to have the flexibility to accommodate the totalinactivation of either the mentioned bacterial or viral contaminationsconcurrently or separately as they may exist or as they may evolve.

The scientific community acknowledges that through the end of 2015 thevirus anticipated to give cause for a pandemic still is evolving and inthe end may carry with it Avian Influenza which could include a strainwhich provides for the spread of human-to-human illness which as so farexperienced causes a death rate approximating up to 40 percent of thoseafflicted. Without certainty as to the end result of that evolution theH5N1 virus or its derivatives is considered to be the likely base sourceof the virus. Until the evolution is complete a countermeasure likenedto Tamiflu or a vaccine is unavailable. Published reports indicate thatboth the US-FDA and the US Department of Health and Human Servicesseparately are dealing with both Canadian and French firms to researchand to develop a vaccine which addresses the level of inactivationrequired to inactivate the still evolving H5N1 virus. Under the new artdescribed herein the ratio between bacteria and viruses for theirrelative inactivations uses the time and temperature formula created inthe 1970's for salmonella inactivation as the base standard employed.That base standard has been utilized to create a ratio for inactivationbetween salmonella as measured by Se and viruses as may come to be foundwithin chicken eggs. Various elements of the scientific community haveengaged in studies involving the relative inactivation levels betweenbacteria and viruses after the employment of heat using Se as thebaseline measure. Those studies included a report that a ratio of a 5-to 7-log inactivation of Se is required to equate to a 5-loginactivation of the H5N1 virus which is performed through the employmentof heat. Notably the referenced report as is further confirmed throughother studies of record provides a ratio of inactivation between thevirus and the strain of salmonella but does not address totalinactivation of either. That determination is not static. As found witheither or both viral and salmonella contamination when present absent ofprompt and deep chilling from lay to table such provides for lethalmultiplication levels to occur in a period of time which matches insubstantial part the timeframes commonly existing between date of layand human consumption if adhered to in practice. If not, the health riskalready present is materially magnified. Without the benefits of prompt,continuous and uninterrupted deep refrigeration which is known to be notreliably available the statistical multiplication of either of thementioned pathogens containing levels of contamination both allowed orresulting from mishandling is such that the multiplication result withina contaminated egg may reach hundreds of millions of cells during thetimeframe most consumers would expect the subject eggs to be safe forconsumption.

Notably and significantly the mentioned elevated levels of cells asderived from both salmonella bacteria and now potentially from viralcontamination are most lethal to risk group members of compromisedhealth which represent a significant portion of the population whosenumber as published by US Government sources as stated above in thissection approximates 150.0 million persons. The cost per illness forcitizens of ordinary health as carried by the US-FSIS is $20,000. perillness which is substantially lower than the costs per illness asexperienced by many portions of the members within the so-mentioned riskgroup representing 45% of the total population. Using the Governmentstatistic of 150.0 million persons as being within the high risk groupsand using an average of 20 dozen eggs consumed per person annually ofwhich only six individual eggs converted into six liquid egg servingspasteurized to a 5-log level of inactivation the likely end result wouldbe six illnesses to 150.0 million persons within the Risk Group categoryat an average cost per illness as carried by the US-FSIS to be $20,000per illness for persons of ordinary health in the end would equate to anavoidable public cost of $18.0 trillion which as of year end 2015equates to the National Debt.

Those described illnesses and their frequency both are understatedknowingly in order to retain the focus on the availability of theenormity of avoidable public costs created for decades primarily fromeither failures in Government oversight or misinformation passed throughto the public at large.

The new art described and claimed herein succeeds in providingeffectively total inactivation of viruses through a 10-log level ofinactivation which automatically inactivates the less heat-tolerantsalmonella strains as may be present within chicken eggs while at thesame time preserving both a capacity to achieve higher logs toaccommodate further mutations requiring greater heat resistance by theviruses as they continue their self-protecting evolution. Under the newart the preservation of the functional characteristics of a raw chickenegg post-pasteurization is retained as is the preservation of thenutritional benefits contained within an uncontaminated fresh chickenegg.

Notably, the average per capita consumption of chicken eggs in theUnited States actually exceeds 20 dozen per annum which is understatedhereinabove for conservative purposes to be 20 dozen per annum. Thestatistical illustration provided for the public health cost stemmingfrom contaminated liquid egg product using a minimal frequency of six(6) 1-egg liquid servings provided to risk group members annuallycurrently pasteurized to a minimum of a 5-log level of salmonellainactivation as measured by Se creates the public cost carried above of$18.0 trillion. The frequency of consumption is understated deliberatelyto avoid disagreement over the quantity of consumption and to allowfocus upon the most important issue of the illnesses caused bycontaminated liquid egg product together with their associated costs tothe public. In support of the above representation that the illustratednumbers employed are conservative salmonella-contaminated chicken eggsfor decades have been reported by Government agencies through to thepresent as being the largest single cause of foodborne illnesses.

Used only as one illustration new viral strains such as the H5N1 requirematerially greater log reduction for their inactivation than do strainsof bacteria in order to provide the public with statistically completesafety which is a primary subject and accomplishment of the newinventiveness as identified, explained and claimed within thisApplication. Such is accomplished through a new ability to inactivateviruses which over time may further increase their heat tolerance andrequire still greater log reduction for inactivation which also isenabled under the mentioned new inventiveness. The above-referenced artuniquely performs the levels of pasteurization required as measured inlogs well in excess of current art without damage to the chicken eggs interms of loss of either their raw aesthetic characteristics orfunctional characteristics while at the same time providing totalinactivation of the targeted viral contaminates. The inactivation ofviruses as measured by log reductions carries with it a higherinactivation of bacteria due to the greater heat sensitivity of thebacteria as found within chicken eggs over that of viruses as foundwithin chicken eggs as confirmed by USDA researchers.

For clarity and emphasis the new art described and claimed hereinelsewhere in greater detail provides for levels of heat inactivation ofthe targeted pathogens found within chicken eggs by sequentiallyincreasing and decreasing the temperature of the heat transfer source toavoid cooking of any element found within the chicken eggs whileachieving targeted log levels of inactivation of the mentioned pathogenswhich are complete. Concurrently to the described purposes beingperformed the controlled fluctuation of temperature as applied to eachegg within its shell is adjusted in terms of temperature and duration ofexposure of the contents of the subject egg. That adjustment providesfor the cumulative but not continuous application of heat to protectagainst cooking of any of the four basic elements within the chicken eggby taking advantage primarily of the speed of heat transfer of the outeralbumen and taking advantage of the level of heat tolerance found withinthe vitelline membrane and the yolk to not coagulate from modestoverexposures to the heat being applied.

Curiously but notably prior to the effective date of the US-FDA Rule ofJuly, 2009, the US Department of Health and Human Services in September,2005, executed a contract with the American branch of a French firmlocated in Swiftwater, Pa., which reportedly contained a deposit of $91million to develop a vaccine to counteract the potential virusidentified as the H5N1 which was considered to be the likely cause of apandemic feared to be in the making. The total anticipated cost for thatwork was confirmed to be $150 million. More or less concurrently theUS-FSIS in a communication to the US-FDA entitled Draft Risk Assessmentdated October, 2005, recommended that a 6-log inactivation of Se throughpasteurization should be included within the proposed US-FDA Rule whichwould represent the log level required to inactivate salmonellacontamination as found within chicken eggs as co-mingled into liquidproducts. In 2009 the US-FDA published the Egg Safety Final Rule whichspecified that known-to-be highly-contaminated chicken eggs could beco-mingled into liquid egg product and be labeled as ‘PASTEURIZED’subject to a 5-log level of inactivation of Se. The above recitationraises obvious questions as to why and how both of the mentionedagencies persisted in claiming that an adequacy of safety existed undereither or both pasteurization levels mentioned as applied to Se whenboth agencies clearly understood that stale eggs were being repackagedwith current dates and levels of salmonella contamination obviouslyfailed at 5 logs to inactivate the subject chicken eggs as provided tothe public at large even when the eggs were relatively fresh andpasteurized to 5 logs which targeted Se as the strain. Further to theabove in-shell eggs packed for foodservice bore no “Best by” dates butwere allowed to include slightly more than two (2) eggs per dozen beingof Grade B quality. Similarly in-shell chicken eggs packed for retailconsumption were allowed to include two (2) Grade B eggs in each dozenbearing a USDA Shield and so-marked as either Grade A or Grade AA. It iscommon knowledge within the industry and the scientific community thatGrade B eggs at great frequency are inferior in many regards but alsomost frequently are salmonella contaminated. The inclusion of Grade Beggs without notice to the public offers one of multiple reasons whystatistically the frequency of illnesses from chicken eggs has not beenreduced for decades from the original ratio of 1 egg in 20,000 eggsbeing contaminated although over the same span of time the consumptionof chicken eggs has risen from 3 billion dozen per annum to recentreports published in 2015 carrying in excess of 7 billion dozen beingconsumed annually in the United States. Still more notably all of theabove-recited abuses reflecting upon the integrity of the agencies ofjurisdiction together with the significant increases in publicconsumption confirm in the first instance why contaminated chicken eggsremain to be each year for more than 20 years the leading cause offoodborne illness which because of increased consumption over the pasttwo or more decades has given cause to a statistical increase inillnesses approaching threefold. Notably, in the second instance theelimination of that source of public expense together with itsassociated hardships would equate to the elimination of the NationalDebt in one year. The subsequent use of those proceeds at the leastwould provide for improved public education across the whole nation,free health care across the nation together with research anddevelopment for our military together with significantly improvedresources for homeland defenses.

A significant feature of the new art contained within the herein claimedand described new inventiveness is that the elements of inventivenessemployed do not target solely the strain of salmonella identified as Seas does the US-FDA, but the new inventiveness described and claimedherein targets other strains of salmonella as found within chicken eggswhich are more heat-resistant than Se. The new inventiveness withoutcompromising the maintenance of the aesthetic and functionalcharacteristics of a raw chicken egg successfully destroys those viraland salmonella contaminants requiring materially greater heatapplication for their destruction than does the present 5-log level ofdestruction of Se as enabled through the quantity of heat employed undercurrent art as is used for both in-shell chicken eggs or liquid eggproducts. The described materially improved level of destructionprovides for total inactivation of the targeted pathogens whetherbacterial or viral as enabled by unique but controlled intermittentapplications of heat together with the intermittent denial of certainlevels of heat. Said protocol which is a part of the new discoveriesreported herein through its application of heat when targetingindividual strains or sub-strains of salmonella not limited to Seprovides for optional levels of heat application which can be employedthrough computerized programs employed to meet the needs at hand. Thoseneeds may manifest themselves through requiring even still greater logreductions of the targeted pathogen which may be either bacterial orviral or a combined presence of both. Under the circumstances of bothbeing present such may require expansion of the protocol employed as isuniquely enabled by the new inventiveness described and claimed herein.That enablement of the protocol employed is both new and unique. Bycomparison prior art has materially lesser ability to utilize thementioned options of inactivating salmonella only or viruses only orutilizing one protocol through its capabilities to achieve the necessarylevel of destruction of both salmonella and the more difficultinactivation of viruses while at the same time retaining the nutritionalintegrity of the eggs together with the retention of their aesthetic andraw characteristics. The new art provides through its availability ofoptions contained within the described unique features of the protocolemployed the enablement of the destruction and inactivation ofadditional strains of salmonella which are more virulent and heatresistant than Se while at the same time providing the ability tototally inactivate viral contamination which requires still greaterexposure to heat than does salmonella. Not only under the new art arethe needed levels of inactivation mentioned available but also anadditional unique ingredient contained within the protocol of the newart is the attention provided from the medium employed forpasteurization which is unique unto itself in providing layers ofsecurity against both recontamination as well as the assurance of totalinactivation of targeted pathogens occurring within the protocolemployed. Notably, no prior art justly can claim total inactivation ofall strains of salmonella as found within chicken eggs, nor is there anyevidence that any prior art can justly claim success in the inactivationof viral contaminants currently evolving as identified above withoutdamage to the raw characteristics of the subject chicken eggs.

Importantly, prior art targets only Se and only employs a 5-logreduction to whatever level of Se contamination may exist. The oneexception involved the H3N1 virus which for decades mistakenly wasconsidered to have the same level of heat inactivation as that of Se.That error exposed millions of people to illnesses resulting from themistake of treating the H3N1 virus as having the same level ofinactivation as Se when co-mingled into liquid egg product. The newinventiveness provides for materially greater safety benefits over thementioned prior 5-log level of destruction of Se as set by the US-FDAwhich does not specify the inclusion of substrains of Se requiringgreater heat exposure for inactivation. However, under the new art aminimum of the doubling of the destruction of Se which fully inactivatesall salmonella which may be present including more heat-resistantstrains of both salmonella and those still greater heat-resistantstrains as found in virus strains are totally inactivated.

Notably and materially were either the viruses or the bacteria throughfurther mutations to come to require higher levels of inactivation thenew inventiveness provides for expansion of the protocol employed thatis unique from all prior art and accommodates the need for greatercapacity to perform the level of inactivation required. That describedexpansion of the destruction capabilities of the targeted contaminate asenabled under the new art provides for total protection againstcontinued gains in heat resistance which occur within both bacteria andviruses as their protective measure for survival. The new art providesfor a level of total safety to be maintained even were new and moreheat-resilient strains of either or both viruses and salmonella toevolve. Protection from loss of nutritional, aesthetic or functionalcharacteristics as compared to raw chicken eggs is preserved. Notably,the collection of benefits available under the new art were notavailable under prior art.

In summary, the new inventiveness described and claimed herein for thefirst time enables the public to be provided with a safe egg suitablefor consumption under all recipes and by all risk groups through theachievement of statistically total inactivation of both viruses andbacteria which currently exist or are forecasted to soon come to existgiving cause to illnesses inordinately magnified by their ability tosucceed in human-to-human transfer. The new art not only inactivateslevels of contamination as found within chicken eggs stemming fromtraditional levels of salmonella when in chicken eggs but also providesfor the inactivation of anticipated strains of viruses and theirexpected requirements for inactivation. Notably and of great importancethe new art allows for the current abuses of mislabeling of products andthe understatement of the risks present within current chicken eggproducts to be eliminated through the achievement of doubling at minimumthe level of pasteurization while preserving all of the qualities foundwithin a raw chicken egg. Such is accomplished through the new artcontaining in part a unique ability pertaining to the application ofheat at greater levels which statistically inactivates all viral andbacterial contamination that either currently exist or may come to existat higher levels as forecasted by the scientific community. Notably thenew art achieves the described inactivations while at the same timepreserving the raw characteristics of a chicken egg together with itsnutritional values. As discussed in significant detail hereinbefore thenew art relies upon a unique protocol whose ingredients stem from therate of heat transfer and denial as applied to the outer albumen andconverts that knowledge into a new formula which protects the outeralbumen from heat damage but allows for uninterrupted and continuingpasteurization to occur through a unique protocol which provides for theintermittent application of heat and its denial that includes allelements of the subject eggs on a continuous but programmed basis as tolevels of intensity which is novel.

As further background to the above recitation concerning the currentstatus of pathogenic development through continuing evolution togetherwith countermeasures made available through the above-outlined protocolemployed as contained within new inventiveness attention is drawn to theUS-FSIS which provided input to the US-FDA for what became the EggSafety Final Rule of 2009. Notably, the US-FSIS in part confirmed in itsOctober, 2005, Risk Assessment that a deficiency exists within theUS-FDA-sponsored Rule of 2009 which supported the need for moredestructive levels of salmonella bacteria separate and apart from thenow present even greater need for materially increased log levels ofdestruction to inactivate still more heat-resistant viruses which arenow the predicted source of a pandemic as confirmed by members of thescientific community located around the globe.

The US-FDA sponsored Rule as enacted in 2009 addresses only salmonellabacteria contamination as limited to Se and its destruction madeavailable under a 5-log pasteurization protocol. Not only is thatsingular item important and pertinent to an overall underlying problemfrom which the public at large is at risk of consuming illness-causingshell eggs or egg products but also the referenced observation by theUS-FSIS that a 5-log level of destruction of Se through its inadequacyto inactivate all salmonella which may be present opens the door for thediscussion of added public peril from chicken eggs or egg productsinadequately pasteurized to provide the public with proper safety.Specifically, the US-FSIS in its advisory role to the US-FDA as providerof the statistical ingredients contained within the mentioned Rulerecommended that the minimum pasteurization level for destruction of Seas measured in logs be changed by the US-FDA from 5 logs to 6 logsbecause of demonstrated inadequacies to inactivate all salmonella whichmay be present albeit that the US-FSIS mentioned 6 logs in the end toois inadequate for public safety.

Materially and notably in pertinent part the US-FDA in its Rule rejectedthe US-FSIS recommendation that the log level of destruction for Se asfound within liquid egg product be raised to a 6-log level ofinactivation. Notably co-mingled liquid egg product had enjoyed for morethan a 20-year span a salmonella log reduction of only 4 as measured bySe. During that timeframe the liquid egg product industry claimed thatnot one salmonella-caused illness had been traced back to a liquid eggsource. Notably, the mentioned US-FSIS recommendation of a 6-logprotocol was targeted directly at liquid egg products, but through theUS-FDA Rule in its final form the same log level of destruction forco-mingled liquid egg product and in-shell eggs was established to be 5logs for both as measured by the inactivation log level required for Sewhich contained the unsaid of the subject eggs being pasteurized anddeeply refrigerated promptly post-lay and required uninterrupted anddeep refrigeration to be present through to consumption. None of thoseingredients in practice is either feasible or reliable for the trustbeing asked from the consuming public. The rejection by the US-FDA tothe recommendation of the US-FSIS regarding the described increase ofthe level of inactivation of Se when found within chicken eggs to 6 logswas compounded as an error by an action taken by the US-FDA within thesubsequent language of the referenced Rule of 2009. The error within theRule enables so-marked, highly Se-contaminated chicken eggs to beco-mingled with other chicken eggs and to be converted into liquid eggproduct pasteurized to a 5-log level of inactivation of Se as thesalmonella strain of measure. Notably the above-described co-mingling ofhighly Se-contaminated chicken eggs pasteurized to a level only of 5logs as measured by Se created and continues to create a major risk topublic health which not only sickens millions of persons annually butalso of notable consequence gives cause to avoidable medical costs whichannually equates to the current National Debt or more as mentionedearlier. Of particular added note the mentioned costs would be magnifiedwere viruses to create greater numbers of illnesses over those currentlycaused by salmonella. The Pandemic of 1918 carried with it a viralsource which killed an estimated 50 million when the world populationapproximated 1.5 billion i.e. one-fourth of its current size. In theUnited States alone an estimated 15 million people perished. Notably ina 12-month span running from 2009-2010 a pandemic carrying with it verylittle publicity occurred within the United States only. The pathogenwas viral, but the source remained uncertain. The number of illnesseshaving occurred in the mentioned 12-month span equated to 60 million. Anadditional 12,000 persons died. Notably, the quantity and speed in whichthat pandemic occurred gained next to no publicity, and what little didoccur was reported only after the crisis passed. Under the exposurespreviously described that threat may only be a forewarning, but theability to reduce the risk finally of chicken eggs giving cause to astill greater pandemic or being protected as a source of food whenneeded during a pandemic makes obvious the benefits of the eliminationof both a viral and bacterial source of illness when such is available.The savings previously referenced not only can be put to good use asalso referenced but could include the development of science whichmagnifies the protection of other food sources as well.

The above-recited events and differing positions by agencies aspertaining to chicken egg product safety are found to be furtherconfounding when considered together with the common knowledgethroughout Government agencies as confirmed by published papersgenerated by USDA scientists more than four years earlier describing thethreats from Avian Influenza as already existing together with arequirement that the subject influenza strains required two (2) extralogs over all salmonella strains as found within chicken eggs for theirinactivation. Certain studies were performed by Drs. Richard Gast andDavid Swayne of the USDA, Athens, Ga., Research Laboratory.

Since the enactment of the US-FDA-sponsored Final Rule of 2009 nomaterial modification to the pasteurization requirements ormodifications of labeling of egg products and shell egg cartons hasoccurred. Notably not only have the inadequacies for pasteurizationcontinued to mislead the public through either wrongful labeling ornon-labeling of both pasteurized shell egg cartons and liquid eggproduct cartons but also no acknowledgement has been sponsored ordiscussed publicly concerning the now known to be serious threat of apandemic as may be caused in material part by chickens and their eggsthat may be contaminated by Avian Influenza strains requiring materiallygreater heat exposure for their inactivation than do salmonella bacteriastrains of which Se is among those that require less heat forinactivation than do viral strains. Of even greater concern, the publicis unaware that a 5-log level of pasteurization of Se inadequatelypasteurizes either or both in-shell chicken eggs or liquid egg products.The inadequate pasteurization results in the continuing presence ofsalmonella whose cell count presumably has been reduced to a level whichwhen deeply chilled can be provided to a consumer at times later as mostoften include weeks to consume without risk of illness. Thatdetermination by the US agencies of jurisdiction is flawed for a varietyof reasons which include but are not limited to the allowance of highlycontaminated eggs as enabled under the US-FDA Rule of 2009 to beco-mingled into liquid egg product which when pasteurized to 5 logsremains to be a high risk to public health unless hard-cooked. Norecommendation is provided to the public that liquid egg productrequires hard-cooking. Further, the reliance upon uninterrupted deepchilling from lay to table defies logic as being safe for reasons thatinterruptions to deep chilling are frequent which is compounded by thefrequency of the time span from time of lay to deep chilling beingapplied promptly to avoid inordinate multiplication of either bacteriaor viruses to inordinate levels which only can be inactivated throughhard cooking of eggs or the effective doubling of the number of logscurrently being employed to perform pasteurization. Such is compoundedby the practice of repacking unsold and stale eggs to be sold as fresheggs. That practice creates inordinate additional risks of illnesses.Further to the above the practice of co-mingling Grade B eggs with GradeA or Grade AA eggs on its face should be a criminal offense. The date oflay should be made clear to foodservice users which currently is notpracticed. The described present inadequacies of current pasteurizationfocusing its target nearly exclusively upon Se as found within chickeneggs is an error which is compounded by new threats which result fromthe need to expand the application of heat required for inactivation ofSe in order to create safety from viral contamination. More notably achronic error has persisted regarding the level of inactivation providedfor Se in that a 5-log level of inactivation has been employed whenlong-standing science has required a 10-log level of inactivation. Byrelaxing the 10 logs to the current 5-log level such only can bejustified were the speed within which the pasteurization to occur to beaccelerated to a point in time that is so prompt post-lay that the wholeegg industry would need to be changed from all current practicesregarding egg processing together with their distribution. Notably theabuses occurring in storage, washing with dirty rinse water, mislabelingof egg grades, co-mingling of known-to-be inferior eggs with highergrade eggs and allowing for inadequate pasteurization to cite only a fewof the chronic abuses all require remedies which only can be found in apractical sense that would be abided by were pasteurization to beprovided at a level which science can demonstrate to provide for totalinactivation of the targeted pathogen. For these purposes the new artdiscussed herein targets a 10-log inactivation for viruses and a 12-loginactivation for bacteria which can be expanded were new strains ofeither pathogen to require such.

As only one illustration of the public health risk enabled by delays inconsumption of Se-contaminated chicken eggs from farm to table, aserving of the equivalent of 1.5 co-mingled eggs less than hard-cookedmay contain approximately 570 salmonella cells from time of lay toprocessing. In the absence of deep refrigeration in a span of 33 daysfrom date of lay the multiplication of Se will achieve in excess of 1billion salmonella cells under average ambient temperatures whichnullifies the intended benefits derived from a 5-log inactivation of Se.Not only have the described inadequacies concerning inactivation ofpathogens not been conveyed to the public but also the term‘PASTEURIZED’ continues to be employed on in-shell egg cartons and uponliquid egg product cartons which magnify the already high risks ofillnesses to unsuspecting consumers since the consumers are unaware ofthe inadequacy of a 5-log pasteurization protocol to provide safe eggsfor consumption when less than hard-cooked. Significantly, through thelong-established knowledge of pasteurization of milk providing forpublic safety, the misuse of the term ‘PASTEURIZED’ resulting from a5-log level of inactivation only of Se in chicken eggs represents ablatant misrepresentation to the public's well-being. Since it isunlikely that chicken eggs will receive prompt, deep and uninterruptedrefrigeration from farm to table the vast majority of the in-shellchicken eggs produced annually for consumption either as in-shell eggsor as liquid egg product exceeding 7 billion dozen will travel fromdate-of-lay through date-of-consumption with interruptions to their deeprefrigeration causing frequent levels of salmonella multiplication to anextent which is lethal or sickening to the majority of the population.In support of the needs for improvements within egg safety as in partdiscussed Government scientists have been forecasting the potential of apandemic caused by influenza sources for years prior to the Rule of 2009and have long since reported that the inactivation of a virus as foundwithin a chicken egg requires greater levels of inactivation employingheat than do those for the various strains of salmonella. The US-FDARule of 2009 makes no mention of those important matters. Notably andcuriously the agencies of jurisdiction concurrently with the new Ruleengaged in contracts with independent purveyors to provide research anddevelopment for a vaccine to be employed were Avian Influenza to becomea threat to public health as already had been forecasted by the WorldHealth Organization and was already under study by the USDA ResearchLaboratory located in Athens, Ga. Notably the research and developmentfor a vaccine may be years away from completion which rightfully maycause an element of risk to the population at large resulting from theforecast by WHO that the makings of a pandemic identified as the AvianInfluenza are being experienced globally. Accordingly WHO repeated hasstated that a pandemic from avian causes is inevitable and already is inthe making. That forecast by WHO is reconfirmed by the already-recitedabove pandemic which occurred within the United States bracketing theyears 2009-2010 which was costly, sudden and unpredicted.

Significantly through the employment of a new and unique protocol whichpreserves the raw characteristics of the subject eggs together withtheir nutritional benefits and performs such through doubling theexisting 5-log level of destruction which provides for the totalinactivation of not only the H5N1 virus but also other viral strainsalready reported to be evolving. The new art as herein disclosed enablessuccessful protection through elevated pasteurization levels provided bythe employment of the new inventiveness claimed herein. Thatinventiveness employs new art which contains protocols enabling thetotal inactivation of both highly contaminated chicken eggs containingsalmonella as well as the more heat-resistant viral strains eitherpresently threatening public health or anticipated to do so. Under thenew art the total inactivation of both viral strains and salmonellastrains whether present or evolving is achieved while preserving thenutritional, aesthetic and raw characteristics of a chicken egg.

To avoid confusion the current protocol continues the custom of theUS-FDA to use Se as the baseline targeted pathogen together withreferences to logs resulting from pasteurization as applied to Se. Thenew protocol enabling materially improved levels of pasteurizationabandons the 5-log level of inactivation of salmonella only for reasonsof its inadequacy to destroy all pathogens present and of at least equalimportance provide the consuming public with a false sense of safety.The mentioned ‘5’ Se logs is endorsed and approved by the US-FDA toprovide safety to the consuming public. That 5-log level is replacedunder the new art described herein with a pasteurization art whichachieves a 12-log level of inactivation of salmonella which equates to a10-log level of inactivation of virus strains anticipated to becomepresent within chicken eggs. The need for a 12-log inactivation ofsalmonella stems from the original studies formed by scientists for theUSDA in or around 1990 which demonstrated that a 10-log level ofinactivation of all strains of salmonella as found within chicken eggswas required to provide farm-to-table safety to the public. When theprotocol employed for liquid egg product pasteurization failed topreserve raw characteristic a compromise to satisfy the egg industryoccurred. Without public notice the pasteurization level was reduced to4 logs to preserve raw characteristic. What was missed was that eggscontaminated with salmonella only have a 4-day grace period before rapidmultiplication occurs. In practice the eggs being pasteurized includedthe worst of the worst which had no hope of being co-mingled and be safefor consumption by the general public unless either hard-cooked orabandoned from being provided. The target of 10 logs as made availablefor new viruses under the new art contained herein as confirmed throughscience equates to 12 logs as applied to salmonella strainsAdditionally, were the 10-log level of destruction of the H5N1 virus tobe found to be inadequate for assured public safety from eggs preparedin all fashions notably and uniquely the new invention through itsexisting feature of flexibility as enabled by both heat exposure andheat denial to the targeted chicken eggs through implementation of itsprotocol described enables the pre-selection of the targeted log levelof inactivation of the targeted pathogen to be automatically programmedin advance which in this illustration would be at a setting in excess of10 logs as applied to viruses. Those protocols not only would beunderstood by one reasonably skilled in the art but also contain uniquerefinements over all prior art which equally would be understood andincludes impact from such items as egg sizes, water content andadjustments to the protocol employed which reflect the log leveltargeted for the total inactivation of the pathogens selected not onlyas applied to viruses as a group and salmonella as a group but also theindividual pathogen strains and their substrains together with theirdiffering resistance to heat. The details of the described art arediscussed within the section entitled ‘Detailed Description of theInvention’ as found herein below.

The following represents a brief summary of critical points regardingreported levels of contamination of chicken eggs together withcommentaries on reports which demonstrate interagency errors andcontradictions as to both the quantity and frequency of chicken eggcontamination together with the quantity and frequency of illnessesstemming from those sources.

One important purpose of the recitation below is to provide a sense ofurgency based upon the mentioned prior history of Government agenciesfailing to find a common resolution of the topic surrounding illnessesstemming from chicken eggs contaminated by salmonella and to avoid asimilar occurrence concerning viral contamination which inherentlycarries with it a highly-magnified public health risk. It isacknowledged that US Government agencies already have engaged theservices of independent scientists to prepare a vaccine to protect thepublic against a strain of influenza which may result in a pandemic. Aslearned from studies of salmonella strains and frequently on an annualbasis as is experienced with strains of influenza vaccines it is commonknowledge that both viruses and bacteria evolve in a manner to protectthemselves. The one common denominator which may be less costly and moreeffective or at the least provides added protection to a vaccine can befound in pasteurization performed at levels of inactivation which resultin the total elimination of the targeted pathogens when performed withinan environment which through design and protocol prevents bothinadequate pasteurization to achieve total inactivation of pathogenstargeted and simultaneously provides for protection againstrecontamination of the subject chicken eggs through less than totalinactivation of the targeted pathogens. Uniquely and notably thosestandards for total inactivation of both of the mentioned pathogens areachieved by the protocol contained within the new inventiveness claimedherein.

Secondarily, a solution to and in preparedness for reliable publicprotection from viral contamination resulting into expanded numbers ofillnesses which may include pandemic proportions enabled by AvianInfluenza in part can be avoided through the methodology now availableand disclosed herein which eliminates chicken eggs as a contributingsource of illnesses. Such warrants a sense of urgency for agencies ofjurisdiction to initiate steps to protect the public not only from theinadequacies of current public policy concerning chicken eggs but alsorequires those same agencies to pay heed to experts within the field ofpublic health including but not limited to WHO that a pandemic causedfrom Avian Influenza is either imminent or already through itsbeginnings is upon us and countermeasures to protect the public and thefood supply require prompt attention in advance as such is available inpart as applied to chicken eggs. The technology described herein belowenables protection of one element of the food supply and denies thatsame element giving cause for increased numbers of illnesses. Even werethat protection not to occur in the magnitude of a pandemic theinadequacies of current pasteurization requirements concerningsalmonella and existing but threatening strains of viruses impactingupon chicken eggs would result in placing the public in greater harm'sway unnecessarily which otherwise would be avoidable. The increasedrisks are avoided through the new protocol disclosed and described ingreater detail herein below under ‘Detailed Description of theInvention’.

Further to the above even were viral contamination of chicken eggs notto occur but were current levels of salmonella-causing illnesses fromcontaminated chicken eggs to continue at present levels along with theallowed for inclusion of only 1 of 2 contaminated Grade B eggs to beincluded within each dozen of so marked Grade A eggs each causing 1additional illness to that which is caused otherwise such would add byitself $80.0 trillion to the cost of illnesses from either previouslycontaminated or improperly marketed chicken eggs.

Were the pandemic as forecasted to occur as caused by viralcontamination the cost in lives would be enormous. Through providingsafety to the egg portion of the food supply chain a material reductionin human suffering and monetary costs would occur. As an additionalbenefit derived through the new inventiveness described herein thechicken eggs once pasteurized under the new protocol change from being asource cause of illness to a needed source for safe and nutritious food.Here follows a list of issues and facts which aid in understanding thehistorical inadequacies of responsible agencies to provide adequateinformation for protection against salmonella-caused food poisoning asfound within chicken eggs which in part could be the result ofinadequate science. Such is provided to enable the distinguishingdifferences and inadequacies of prior art as compared with the new artwhich contains the ability to provide the public with the deservedprotection available that materially will contribute to its survivalthrough reducing the quantity of illnesses while at the same timepreserving a major element within the basic food supply.

1. The US-FDA-sponsored Rule of 2009 provided for the co-mingling ofknown-to-be highly Se-contaminated chicken eggs with other eggs andtheir conversion into liquid egg products if pasteurized to a 5-loglevel of inactivation of Se before being provided to the public with aclearly implied representation of safety which made the subject eggsmore attractive to be consumed by all risk groups within all recipesabsent of hard cooking.

2. The authorized label of ‘PASTEURIZED’ without Safe HandlingInstructions of any nature concerning limitations to preparationregarding health risks unless hard-cooked has continued to be found onegg cartons containing in-shell pasteurized eggs which require a 5-loglevel of pasteurization of salmonella if present.

3. The US-FSIS has gone on record as stating that a minimum of 6 logs isrequired to inactivate Se as a threat to public health when found withinchicken eggs. As noted above the US-FDA subsequent to the US-FSISrecommendation allowed the lesser 5-log level of Se inactivation to beemployed as applied to both liquid egg product and in-shell chickeneggs. Notably and pertinently current science breaks down not onlysalmonella into various identified strains but also provides a breakdownof the Se strain into various sub-strains which include a more virulentand heat-resistant presence within the mentioned substrains.Confirmation of such can be found in various scientific writings one ofwhich is authored by Dr. Richard Gast of the USDA Research Laboratory aspublished in 2011. Of particular and pertinent note to the mentioned Sesubstrains is that their very existence adds to the confusion as to whySe and not its substrains is selected to receive a targeted 5-log levelof inactivation when its own substrain requires a higher level ofinactivation.

4. As recently as April, 2014, egg cartons within the New England areadisplayed a ‘Best By’ date of 30 days while at the same time inmaterially smaller print under the heading of ‘Safe HandlingInstructions’ the public is provided with a notice that unlesshard-cooked eggs may be harmful to one's health. Further, 5-logpasteurized liquid egg products and in-shell chicken eggs have no ‘SafeHandling Instructions’ on their containers, but along with US agencyauthorization for improved public understanding do display the term‘PASTEURIZED’ in a large font size without the otherwise required ‘SafeHandling Instructions’.

5. When packaged for retail the date employed for either ‘Best By’ orother comparable language displayed upon retail egg cartons is providedfor the public to understand the relative timeline of freshness andimplied safety as determined by the noted language. Materially the dateemployed most often utilizes a beginning point of when the eggs arepackaged and not the date of lay. That described distinguishingdifference is material to the level of pathogenic contamination beingpresent because an already contaminated egg does not becomedecontaminated with refrigeration. In a matter of a 30-day period oftime whether interrupted or otherwise in the absence of deeprefrigeration those eggs if contaminated by either viral or salmonellasources will multiply into lethal quantities as applied to risk groupsunless hard-cooked. Notably the mentioned risk groups represent nearly45% of the population within the United States which equates to a numberapproaching 150 million persons which is increasing annually due to anaging population.

6. As has been recited earlier recent enactments by state and Federalagencies provide for still greater risks of illnesses caused by chickeneggs through extending the ‘Best By’ date to that of 30 days from dateof packaging and notably not date of lay when concurrently it isobviously known as already stated on the egg cartons that the eggsshould be hard cooked to be safe.

7. Notably, if a pathogen i.e. virus or bacteria is totally inactivatedthrough pasteurization the subject eggs do not risk a level ofrecontamination occurring which would be lethal to consumers even wereinterrupted deep refrigeration to occur.

8. The Federal Government passed a regulation in the 1990's to aid inproviding improvements to food processing for public protection. Itcreated a plan that was enacted into law which was intended to identifyhazards existing within food processing and to provide for theiravoidance. That plan included a requirement to identify risks which inthe end was intended to improve food safety through attention providedto those identified risks. The name of that regulation and the resultingplan was the Hazard Analysis Critical Control Points which generally isreferred to as HACCP. Pertinently, historically chicken eggs have beenranked as the single most cause of foodborne illness both from thepresent back to at least the 1970's. Egg producers reportedly haveconformed to the requirements of adopting and filing a HACCP plan.Notably and materially to the claims contained in this document theHACCP requirements are not only violated in substantial part throughdelayed collection and packing of eggs prior to deep chilling but alsoin part are impossible to perform for reason that the systems employedcreate obstacles which block responsible practices to be employed whichresult from circumstances that create opportunities for contaminationinstead of an environment which provides protection againstcontamination. That results in avenues from which the current ease forSe multiplications into lethal quantities occur in the timeframe asexists between farm to table. That environmental enablement to createhigh levels of contamination is further compounded by the failure toachieve immediate and continuous deep chilling from lay through point ofconsumption. Those mentioned flaws in the system stemming from theenvironment of the farm to the product arriving at the consumer tableplaces the public at serious risk through its misplaced reliance uponthe implied protection provided by the USDA Shield as compounded by thefalse information conveyed through the ‘Best By’ date displayed upon thesubject carton whether in-shell or liquid product.

9. The above factors when combined with reliance upon uninterrupted deeprefrigeration applied immediately after lay through consumption does nottake into account the obvious risks of refrigeration interruptionscaused by transportation breakdowns, power interruptions caused byfloods, tornadoes, snowstorms and the like whose frequencies give causefor the agency of jurisdiction to provide an altogether different noticefor the public safety than that which is currently employed asreferenced and described above.

10. No known study provides support whether statistically based orscientifically based resulting from actual experiments involving alreadySalmonella-contaminated chicken eggs which would support newer claimsmade by the US-FSIS as contained within its Draft Risk Assessment ofOctober, 2005, as provided to the US-FDA which states by eitherimplication or as an actual fact that even though 1 egg in 20,000 eggsat time of lay may be salmonella contaminated only one egg in 277,000eggs is contaminated with Se to a level which gives cause to illness.

11. The US-FSIS statistical information as recited above is misleading.In part, by using a reference only to Se as found within the chickeneggs and by further limiting its source as stemming from the chickenovaries without recognizing any other source of salmonella contaminationto the chicken eggs i.e. Se external to the shells, non-Se strains ofsalmonella external to the shells, salmonella and Se accessing throughexposed pores of the eggshells, contaminated rinse water or airbornecontamination to provide external contamination flowing into the body ofthe subject eggs through the shell pores are commonly understood bypertinent members of the scientific community and those within the eggindustry who possess knowledge pertinent to contamination occurringwithin chicken eggs. Hence, the conclusions reached by the US-FSIS thata reduction of inordinate proportions has occurred in the frequency ofillnesses specific to Se as found only within the egg at time of laywhich currently converts into a 12-fold or greater reduction inillnesses is not only materially incorrect but also has no scientificsupport of record. Taken on its face the US-FSIS conclusion reachedwould result from no presence of external contaminants being within thesubject eggs excepting Se as found to occur within the ovaries of thechicken before lay. No statistical evidence to support such exists.

Contrary to the above scientific studies indicate opposite findings fromthose recited US-FSIS findings which is that Se together with otherstrains of salmonella as well as additional contaminants flow fromexternal sources into the subject chicken eggs through the pores of theshells regularly and such is commonly understood by the scientificcommunity which includes independent scientific sources as well as theUSDA Research Laboratory writings. Although the rinse water employed toall chicken eggs before either breaking or packaging is expected to beof higher temperature than the internal eggs' temperatures to avoidtransfer of pathogens into the eggs through their exposed shell poresthat practice frequently is violated as reported by USDA publicationswhich results in all of the exposed eggshell pores receivingcontaminated water which migrate into the body of each egg. Thus,internal contamination of the chicken egg frequently occurs to all eggswhereas contamination stemming from ovaries is measured in frequency asbeing one egg in 20,000. The source of the described frequency is fromthe US-FSIS. From those referenced sources more sophisticatedinformation is provided which in part includes reports on substrains ofSe which require still higher levels of inactivation than does Se. Noreports confirming a materially lessened threat from Se, its derivativesand other strains of salmonella are known to be provided in support ofwhat may well be misinformation resulting from a scientific errorgenerated by the US-FSIS in its published Report of 2005. In the endthose questionable new conclusions place the public at greater healthrisks from chicken eggs than before the referenced US-FSIS report. As afurther confounding matter the US-FSIS report does not challenge thelong-standing generally accepted statistic that 1 egg in 20,000 chickeneggs is salmonella-contaminated.

12. Notably, in a report dated November, 2012, as authored by the USDAOffice of Inspector General reconfirmation of the frequency ofsalmonella contamination as found within chicken eggs at a ratio of 1egg in 20,000 eggs was provided. It is noteworthy that the US-FSIS is adivision within the USDA and previously in a report carrying a date of2005 had reported that the frequency of salmonella as found withinchicken eggs had been reduced to 1 egg in 277,000 eggs.

13. Reference is made to prior discussions within this document whichconcern various questionable practices employed by the industry also asknown to exist by agencies of jurisdiction that are identified anddiscussed in greater detail herein above. Those referenced practicesplace the public in harm's way from misinformation and mislabelingpractices employed as such relate to freshness and quantities ofcontamination as found within chicken eggs being provided to the publicwhich contain fraudulent labeling practices generally known by theindustry and Government agencies but generally unknown to the consumingpublic. More specifically those referenced practices include placing newdates on previously unsold eggs by changing cartons and mislabelingstale and contaminated Grade B eggs through their inclusion within GradeA and Grade AA cartons.

Notably, as stated herein before, Government agencies have contractedseparate firms to create a vaccine for protection of the public from theinvasion of influenza which would impact upon chicken eggs. However,since the Government is well advised as to what science is beingperformed in the subject areas one must conclude that pasteurization ofeggs would be part of a countermeasure to Avian Influenza since the artalready exists to totally inactivate both viral contamination andbacterial contamination as found within chicken eggs. Such would providefor a contribution to lower the impact upon the public from influenzaand to eliminate chicken eggs as a source to spread a deadly virus inlieu of retaining those eggs as a food source at a time of need.

Notably and materially and in contradiction to the implications of itsown prior reports regarding the infrequency of salmonella-contaminatedchicken eggs the US-FSIS published a document dated April, 2011, withinwhich the Agency described the passageway through which an egg is laidand reported on the high frequency of manure attached to eggshells atpoint of purchase by the public. Such not only discredits thesanitization rinse allegedly provided by all producers to in-shellchicken eggs before packaging but also raises questions about eggshellconditions prior to conversion into liquid egg product. It is throughspecific experience the author of this Application has observed it to becommon practice that the rinse water employed at an egg processingfacility commonly is not changed except for at the end of a shift. Theantibacterial agent contained within the rinse water is provided at thebeginning of each shift in many cases. Usually the shelf life of theagent employed is less than 20 minutes and most often can be 12 minutesor less. Thus, the rinse water at ambient temperature frequently isapplied to unwashed and only sometimes refrigerated in-shell eggs whichwarm from the rinse water being applied. That warming provides for theinternal egg to contract which allows for the contaminated rinse waterto flow into the subject chicken egg through what have become theexposed eggshell pores which became exposed through the loss of theirnatural sealant resulting from the rinse water applied. It is commonknowledge within the scientific community and the egg industry that henmanure contains Se. The chain of events described raises the question asto whether the Se-contaminated hen manure flows through the exposedeggshell pores into the body of the egg carrying with it Se which atsome point finds its way through the membranes found below the eggshelland ends up within the body of the egg. Current thinking has it that theSe contamination predominately occurs within the egg beginning with theoccasionally infected ovaries which only intermittently contaminate theegg. The question as to why a hen with salmonella-infected ovaries onlyoccasionally lays an infected egg may be answered by tracking theSe-contaminated manure being washed and entering the subject egg throughits exposed pores which upon certain occasions penetrates the membranesand infects the body of the chicken egg. Either way externalcontamination is confirmed to exist by both logic that manure would bein contact with the eggshell when laid and would be washed into theexposed pores when dirty wash water is employed. The new inventivenessdescribed herein eliminates the risk but does not answer the question.Separately but notably, that chain of events if practiced at all i.e.the presence of manure on eggshells at retail stores not being uncommonmay well be an additional but material source of contamination at therestaurant or household level for reason that the exposed manureobviously attached to an unwashed egg confirms that time enough haspassed for its original liquid presence to penetrate the eggshell poresand to provide contamination of the internal egg particularly whencracked open. Notably, were the egg carton to contain both a sealedenvironment and an antibacterial agent fully housed within the cartonservicing its internal environment a material reduction of both viraland salmonella contamination of the subject eggs would occur and publichealth particularly as found within risk groups would be thebeneficiaries. The inclusion of an antibacterial agent to be housedwithin the contents of the egg carton is to be a subsidiary claim asdisclosed in this document.

In all egg processing plants to display the USDA Shield on the eggcarton requires an on-site inspector. The subject eggs carrying manureattached to the shells obviously were either not inspected oroverlooked. However, the consistency of that nature of contaminatedeggshells indicates that something concerning inspection protocol policymay be involved through which substandard products have becomecommonplace and not simply overlooked.

Comments and Conclusions:

A substandard environment common to modern day henhouses likely is theprimary source of human illnesses resulting from the impaired health ofthe chicken as the vehicle for transfer of contaminants includingbacteria as one example.

All of the issues surrounding the continuous struggle to provide for achicken egg absent of contamination from either viruses or bacterialikely would be made easier and more effective were the conditionswithin the henhouse to be materially improved. If improvements to thehenhouse and its environment were to occur such would produce ahealthier hen which in an improved environment would have less stressand less collateral contaminants to their eggs. In the end the publichealth would be the beneficiary of what reason dictates to be anappropriate environment for a hen destined in captivity to produce eggssafe for consumption while under current conditions that same hen isbeing abused daily. The good health of the chicken would materially aidin the reduction of the frequency of contamination of chicken eggs bysalmonella and likely viruses as well. Unfortunately, as sensible andhumane as the mentioned environmental improvements may be in the endwhat already has been done has not been enough to ensure public healthfrom the perils of salmonella-contaminated and/or virally-contaminatedchicken eggs to continue to be a public health threat. Fortunately theabove references to new inventiveness resolve the open issues of how toprovide a statistically safe chicken egg while maintaining its desirableraw characteristics at reasonably low cost. The details regarding suchare found below under the heading of ‘Detailed Description of theInvention’.

SUMMARY OF THE INVENTION

This invention provides for the total inactivation of all salmonellastrains as found within chicken eggs. Notably and significantly thisinvention includes a unique addition of a protocol which containsflexibilities that enable optional expansions of a base formula whichunto itself contains new art carried within a unique formula forpasteurization of in-shell chicken eggs resulting in both the totalinactivation of the targeted pathogens whether bacterial or viral as maycurrently exist or come to exist without damage of consequence to theraw characteristics of the subject in-shell chicken eggs in all of theirsizes and all of their pre-existing levels of contamination. Separatelyand of equal novel significance and importance to the art described isthe medium within which pasteurization is performed. When employedtogether pasteurization to levels never before achieved is accomplished.Total inactivation of targeted pathogens enabling the safe consumptionof undercooked eggs uniquely is accomplished under an umbrella ofsafety. Risks against recontamination never before achieved also areaccomplished. Through such the public at an affordable cost is protectedfrom illnesses. The magnitude of public savings as measured in dollarsis substantial. That flexibility within the protocol employed toinactivate viruses and their continuing evolution requiring a greaterlevel of heat for their inactivation always exceeds the level ofinactivation required for bacteria i.e. salmonella in all strains asfound within chicken eggs. That new capability is useful when bothpathogens may be present. When not present the same protocol can bereduced in length of application as measured in cycles containing heatgain and denial to inactivate salmonella bacteria were the currentthreat from viral contamination to pass.

Thus the new inventiveness described herein satisfies both the new andadditional needs for higher levels of pasteurization to accommodate thegreater heat resistance of viruses over that of bacteria. Such has beenaccomplished through the application of features contained within thenew art identified and claimed herein whose target when initiated was toinactivate salmonella to a level which was total. During that researchand development process the targeted pathogen of salmonella was modifiedto include viruses which science confirms require greater log levels fortheir inactivation than do all strains of salmonella. That change wascaused by multiple new reports which contained new information on publichealth threats from viral contamination as may come to be found withinchicken eggs. Those threats already had manifested themselves by causingillnesses and deaths across the globe which causes came to be identifiedas Avian Influenza. Those new threats to public health as carried byviruses gave reason for the development of the new inventiveness asdescribed herein before which uniquely inactivates both salmonella andviral strains when present within chicken eggs without negative impactupon the subject chicken eggs in terms of compromising their rawcharacteristics, nutritional values and aesthetic similarity to those ofraw unpasteurized chicken eggs as well as those chicken eggs previouslypasteurized to reduce their salmonella content albeit inadequately. Theapplication of greater quantities of heat to perform the needed addedachievements of total inactivation of salmonella through an improvedpasteurization protocol has lead to discoveries which enable the totalinactivation of viruses as now are described herein and are claimed asnew art. Such new art for improved pasteurization for salmonellabacteria now includes the addition of the ability to inactivate viruseswhich results from a protocol that is both unique and effective toperform such without consequential negative impact upon the aesthetics,functionality and nutritional benefits of the subject chicken eggs ascompared to those same characteristics as found within raw chicken eggs.Now the public has available at a time within which a virally causedpandemic known to be associated with birds so referenced as being AvianInfluenza not only is forecasted but also has shown its potential tokill humans in multiple locations around the globe which sets thefoundation for its magnification into a pandemic as already forecastedby scientific experts located around the globe. The required levels ofinactivation to achieve totality as applied to both bacteria and viralcontamination of chicken eggs requires at minimum a doubling of theinactivation currently employed for salmonella bacteria as found withinchicken eggs in order to provide the public with safety for consumptionof chicken eggs when less than hard-cooked. The scientific communityconfirms that a minimum of an additional 2-logs of inactivation ofsalmonella is required to inactivate viral contamination of chickeneggs. Experience has taught that even when inactivation has beenattempted recontamination persists to be a still greater threat to thepublic. Currently the science for neither total inactivation ofsalmonella nor viruses together with their potential conversions asfound or may come to be found within chicken eggs is available toprovide the urgently needed total inactivation of the pathogens cited.Such now may be accomplished through the expandable features of the newprotocol described which provide for expansion of the pasteurizationtreatment employed to accommodate the inactivation of moreheat-resilient strains of viruses as they may evolve and require stillgreater heat inactivation which is now available under the new artclaimed herein. Such is accomplished through the unique featurescontained within the new art which enables expansion of the quantity ofheat applied to the subject chicken eggs in a unique manner whilepreserving both the benefits derived from raw characteristics and thenutritional qualities as found within chicken eggs while achieving totalinactivation of the targeted pathogens whether viral or bacterial. Theapplication of heat as employed under the new art contains the novel andunique protocol of the intermittent application of heat and its denialwhich blocks coagulation or overcooking of any one element of a chickenegg. Specifically, the new art through both the repetition of theapplication of heat and the preprogrammed denial of heat enable theachievement of higher logs of inactivation. The benefits of higher loglevels not only provide for the necessary improvements to theinadequacies of the current protocol employed for pasteurization of bothin-shell chicken eggs and liquid egg products but also enables theimportant need for the protection of the public health from the millionsof illnesses caused annually from contaminated chicken eggs. Ofsignificant further benefits the new art enables its own expandablefeature through the flexibility of the protocol employed which not onlyallows the achievement of total inactivation of current targeted strainsof salmonella and viruses but also contains the flexibility to overcomeand to inactivate the results of continued evolution of the targetedpathogens which through such continue in an on-going manner to protectthemselves through mutations.

Recent viral presence found within birds including migrating birds anddomestic chickens have given cause for the scientific community toforecast a pandemic stemming from Avian Influenza which include morethreatening virus strains than presently exists. That presence magnifiesthe opportunity for human-to-human transfer which would add to the chaoscreated from a pandemic.

For clarity and better understanding of both the risks to the publicwhich currently exist from avoidable magnification of the results of apandemic from avian causes the following two illustrations are provided.First. the most significant pandemic in modern times occurred in 1918when the world population approximated one-third of that of today.Estimates of mortality from the 1918 pandemic whose source was viralcontamination are in the 70 million death range. Second, a pandemiccarrying little publicity occurred within the United States only withina two-year span of 2009-2010 for a duration of twelve months withinwhich a virus was reported to be the cause. Resulting reports confirmedthat some 60 million people became ill and 12,000 deaths occurred.

The new inventiveness to be described in detail herein below includestwo areas of primary inventiveness:

The first area of primary inventiveness includes a novel protocol forchicken egg pasteurization utilizing the intermittent application ofheat and the denial of heat in a unique manner which achieves levels ofpasteurization of chicken eggs as measured in logs which inactivatessalmonella in all strains as well as viruses in all strains thatcurrently exist or may come to exist within chicken eggs as confirmed bythe scientific community through research results. The following detailsconcerning both of the two areas of primary inventiveness discussedbelow are further clarified within the section following entitled:‘Detailed Description of the Invention’. When read separately thecontents of each apply.

The above introduction introduces the ingredients of new art whichenables pasteurization of targeted pathogens as found within chickeneggs while within their shells to be pasteurized to levels which areaccomplished through the cyclical application of heat and its denialwhich provides for cumulative pasteurization to levels as measured inlogs never previously available without damage to the rawcharacteristics of the subject eggs while still providing to the publican egg for consumption that is safe regardless of the nature of itspreparation whether as a raw ingredient or partially cooked. The artenabling such utilizes interruptions to the base temperature settingsfor pasteurization for measured time intervals to accommodate the eggcharacteristics being processed. Those characteristics include size asmeasured in weight, water content and other features peculiar to thesubject eggs being processed which impact upon the temperatures employedalong with their durations required to achieve pasteurization to thetargeted level of inactivation programmed. All of the above factors areconverted into a formula for pasteurization involving multiple times andtemperatures reflective of the egg ingredients referenced together withother pertinent characteristics which aid in refining the protocolemployed to provide for total inactivation of the targeted pathogenswithout consequential damage to the subject eggs involving qualities ofraw characteristics, aesthetics and nutritional benefits. The durationsof the intervals utilized for applications of heat along with thedurations of programmed interruptions to the applications of heattogether with the applications of induced chilling at preprogrammedlevels and frequencies create variables to the interrupted employment ofthe targeted pasteurization temperature to avoid coagulation of thefragile outer albumen. Those interruptions provide protection to thefragile composition of the outer albumen through promptly reducing itstemperature from the pasteurization temperature setting being employedto one which is below that which causes the continuation of coagulationas is found in temperatures below 128° F. However while the outeralbumen is being protected by the lower temperatures referenced theother elements of the chicken egg more specifically identified as theinner albumen, vitelline membrane and the yolk will continuepasteurization during the timeframe within which the outer albumen isbeing protected from heat damage through residing at temperatures below128° F. albeit that the other elements will continue with uninterruptedpasteurization but at a lower pace. That described process at times isreferred to as cyclical in nature because the temperature applied to thesubject eggs has been elevated, leveled off and held for a prescribedtime at the targeted pasteurization temperature which for theseillustration purposes is selected to be 132.5° F. and subsequent toachieving the target log level for partial pasteurization and to avoidcoagulation of the contents of the subject eggs the eggs are reduced intheir temperature resulting from preprogramming of the timing andduration of the application of heat, its denial and replacement withinduced chilling as measured in time to reflect the characteristicspertinent to that specific batch of eggs which provides for theprotection of the outer albumen from heat damage by exposing and holdingthe outer albumen at temperatures below 128° F. which when the outeralbumen has achieved the proper interruption to heat being appliedcausing coagulation the induced chilling is discontinued, controlledheated and purified water is reapplied and the pasteurization cyclecommences again.

Notably and of significant importance to the new art is the discovery ofthe unique characteristics of the outer albumen as such may be employedsuccessfully to create the ability to perform pasteurization of in-shellchicken eggs at levels of pasteurization which in the end through theprotocol derived from that new knowledge enables inactivation oftargeted pathogens to occur for the first time while preserving both theraw characteristics and nutritional benefits of the subject in-shellchicken eggs regardless of the level of contamination and the differinginternal characteristics together with the outer albumen's uniquecomposition and location within the subject chicken eggs giving cause toit having a higher risk of damage from over exposure to heat.

Most notably, the success of the cyclical nature of the pasteurizationprotocol employed is dependant upon the outer albumen remaining freefrom heat damage which under all prior art gave cause to unwantedcoagulation of the outer albumen in all applications of the protocolsemployed even when those applications never reached reliableinactivation of either all salmonella strains or levels of salmonellacontamination as commonly occurring within chicken eggs and requiringinactivation levels up to 10-logs. The discovery of the role of theouter albumen as influenced by its limitations to heat tolerance is thekey ingredient discovered to enable a protocol to occur which in the endenables pasteurization of chicken eggs to provide for total inactivationof targeted pathogens without loss of the raw characteristics as foundwithin a raw chicken egg. That discovery creates the foundation for thedescribed cyclical application of heat together with its denial whichprovides for the protection of the outer albumen against heat damagewhich enables the new and unique ability to perform the level ofpasteurization which successfully inactivates targeted pathogenscustomarily found or expected to become found within chicken eggs.

Notably, within the formula employed the timed duration of the reductionof heat from the targeted pasteurization temperature selected is basedupon the heat tolerance of the outer albumen. Once that protection issecured the cycle of the application of heat and its denial up to andreduced from the targeted pasteurization temperature employed is resumedand repeated until the targeted log reduction of the targeted pathogenhas been achieved. The described typical application of heat and itsdenial protects each element of the egg and most particularly the outeralbumen from coagulation. However, notably and significantly, that extrastep of intermittent application of heat and its denial uniquely allowsfor log levels of targeted pathogens providing for total inactivation ofall targeted pathogens to occur. At that point the subject eggsoptionally may be provided with a final application consisting of afood-grade antibacterial agent which is applied to the eggshells andtheir exposed pores. The continued contraction of the internal egg drawsthe mentioned food-grade antibacterial agent into the subject eggsthrough its exposed pores which provides for an extra level of certaintythat any stray pathogen surviving is inactivated. The application of thefood-grade antibacterial agent to the exposed eggshells and its poresapplied while the eggs continue to contract internally is followed bythe application of a food-grade sealant to the exposed eggshells alongwith their exposed pores which by preference can be either a food-gradewax or a food-grade plastic. Such is applied while the eggs arecontinuing to contract internally which provides for a more perfect sealand protection from outside risks which unless the eggs are physicallydamaged will continue to protect against recontamination from their exitfrom the medium through to the point of consumption.

In essence all of the above steps and the ingredients outlined incombination represent a unique protocol which includes the employment ofunique features to be performed within an equally unique medium whichprovides for pasteurized eggs to exit from the protection providedwithin the pasteurization medium having achieved total inactivation oftargeted pathogens without risk of recontamination from point ofpasteurization to table excepting for mishandling or unavoidable damage.

A second primary claim within claim 1 refers to a new and unique vehiclefor pasteurization of in-shell chicken eggs that is referred to as thepasteurization medium which periodically may be referred to as themedium.

The second area of primary inventiveness includes a new and uniquemedium as referenced above within which pasteurization of chicken eggsis performed under secured conditions which protect the subject eggsfrom both contamination occurring from internal sources within themedium and separately from recontamination occurring post exit from themedium.

The medium which is new to the art of pasteurization as described hereinis self-secured and contains a combination of features which result in anew and separate art that enables the previously describedpasteurization protocol containing its cyclical applications of heat andtheir denials to be employed. Once the new art has been employed withinthe security of the medium which protects against recontamination of thepasteurized eggs from time of entry into the medium through to theirexit carrying with them at exit the benefits of the achievement ofinactivation of targeted pathogens resulting from the hereinbeforedescribed protocol employed the subject eggs are provided with a finalrinse of an approved antibacterial agent exposed pores of the eggshells.That rinse contains only a food-grade antibacterial agent which is drawninto the contracting eggs through their exposed eggshell pores whilestill ambiently cooling within the protective environment of the medium.That step is followed by the application of a food-grade protectivesealant which provides protection against recontamination from point ofexit from the medium through to consumption. Importantly the mentionedself-secured features of the pasteurization medium are both unique andenable full protection from risks of airborne contamination present orattempting entry into the secured environment of the medium wherepasteurization is occurring. Both the mentioned airborne contaminantscombined with manure and other impurities frequently attached to thechicken eggshells post rinsing prior to pasteurization under prior artprovided for sources of continuing contamination of the eggshells postpasteurization resulting from the transfer of pathogens through theexposed eggshell pores into the internally contracting chicken egg whilecooling post rinsing. Under prior art the residual contamination carriedupon the unclean eggshell not only found a source of entry into thesubject chicken egg through the shell pores but also added to the levelof contamination present within the subject egg which separately or incombination in large part survived pasteurization for two primaryreasons. First, a 5-log level of inactivation of Se as approved by theUS-FDA as the agency of jurisdiction as manifested through its sponsoredEgg Safety Rule of 2009 continues to be inadequate to satisfy the needsof total inactivation of either salmonella in all strains or viruses inall strains existing or anticipated to come to exist. Secondly, as theeggs expanded through the heat being applied during pasteurization thecontamination present within the eggs prior to pasteurization as well asthe contamination attached to the eggshells having flowed into the eggswhen rinsed externally usually at the producing farm level created alarge concentration of pathogens present within the pores of the shells,inside the shells as well as between the two inner membranes containedwithin chicken eggs. Under prior art as the in-shell eggs internallyexpanded during the pasteurization process massive quantities ofcontamination containing salmonella cells already located within theeggs themselves as described were released by force of expansion of theinner contents of the chicken eggs into the atmosphere through using theeggshell pores as their means of exit. Experience gained confirms thateven were an increased level of a negative atmosphere to be employedwithin the presence of the open environment of the pasteurizationprocess employed such would be inadequate to provide absolute andpermanent discharge into the atmosphere of all of the pathogenseffectively being exhaled from the quantity of eggs undergoingpasteurization concurrently. That phenomenon once uncovered gave urgentcause to provide all of the subject eggs whether contaminated orrecontaminated with salmonella to be inactivated before ambient orinduced cooling occurred for reason that when ambient cooling occurredthe mass of eggs through concurrent internal contraction of the largequantities of eggs created a current which attracted inordinate airbornequantities of salmonella cells to relocate themselves onto the eggshellpores. That combination of events gave cause to potentially all of theeggs to be contaminated. That level of risk of recontamination wastraced back to a brief timeframe which occurred from the time lapseoccurring between the eggs exiting the pasteurization medium and beingsprayed within a matter of three minutes with an antibacterial agent toavoid the recontamination which in the end occurred.

Notably and significantly it was learned that no practical quantity of anegative atmosphere within the facility where pasteurization wasoccurring could be relied upon to avoid recontamination. Thus, theprotocol employed not only utilized the now known inadequacies of apasteurization protocol employing a 5-log level of inactivation ofsalmonella as measured by Se but also failed to inactivate salmonellapresent which exposed the eggs subjected to pasteurization torecontamination. Eventually that problem became compounded by thediscovery that the industry by practice rarely cleansed eggshellsproperly and rarely provided deep chilling promptly and continuouslywithout consequential interruptions from farm to table. The crowing blowto the unfortunate chain of events described was the discovery that the5-log level of inactivation of Se as set by the US-FDA at the requestfor a standard to be set by this inventor, Davidson, in 1997 was inerror in that he was advised that a 5-log inactivation of Se wouldqualify for the elimination of the ‘Safe Handling Instructions’ requiredon raw egg cartons which would be replaced with the display of the term‘PASTEURIZED’ It was only after Davidson went to market with his productin 2001 that he learned that without publicity of any nature therequirement for pasteurization of liquid egg product had been loweredfrom 10-logs as established in the 1990's by the USDA to 4-logs asmeasured by salmonella in the strain of Se for reason that the form ofprocessing employed could not provide for that level of inactivation ofsalmonella without coagulating the liquid egg product being processed.That requirement was changed under the US-FDA sponsored Rule of 2009 tomatch the 5-log level of inactivation required for in-shell eggs.Notably, a 5-log level of inactivation of salmonella bacteriaoccasionally but not reliably can be accomplished at 5-logs providingthat the eggs are fresh and are provided with a 5-log level ofinactivation within four days of lay. Significantly and of greatimportance to public health the US-FDA authored and sponsored the EggSafety Rule of 2009 within which it specifically identified known to beand so marked to be highly-salmonella contaminated chicken eggs to beallowed to be pasteurized to a 5-log level of inactivation and to beincluded through co-mingling into liquid egg product which also allowedfor a claim of pasteurization along with no indication to the publicthat a health risk existed through lack of hard-cooking. Similarly the‘Safe Handling Instructions’ were eliminated from in-shell pasteurizedegg cartons and the term ‘PASTEURIZED’ was approved for those eggcartons.

The obviousness of the accommodations to the liquid egg product industryto allow known to be and so-marked to be highly contaminated chickeneggs to be included within liquid egg product without notice to thepublic that the subject eggs when consumed must be hard-cooked clearlyhas cost tens of billions of dollars and untold amounts of avoidablemisery to the consuming public throughout the time since the 4-log levelof salmonella inactivation of liquid egg product was initiated.

The above issues concerning the public's health and pocketbook arecompounded both separately in statistics and costs by more flagrantabuses both long practiced and continuing.

As recited under the above section entitled ‘Background to theInvention’ for illustration purposes only the cost of limitedconsumption i.e. six-one egg servings annually consumed in a liquid formby risk group members when less than hard-cooked will cause an equalamount of illnesses. Using the reduced cost per illness for persons ofordinary health as reported by the US-FDA and the US-FSIS as being$20,000. per illness and using the published number of persons containedwithin high risk groups as being 150.0 million persons the associatedannual cost for the described population consuming a small fraction ofthe eggs annually contained within co-mingled liquid egg product wouldprovide for an avoidable annual public cost of $18.0 trillion. Aseparate and distinctly different statistic reported by a group ofexperts whose organization is entitled NERO reports that slightly morethan two Grade B eggs are allowed to be co-mingled into in-shell chickenegg cartons containing labels of being Grade A or Grade AA. Grade B eggsare known throughout the industry to be of inferior quality and mostfrequently older age and include eggs from flocks carrying salmonella.These generally inferior eggs at a level of approximately 18% per dozenare allowed to be passed through to the public at large under the labelGrade A and Grade AA together with ‘Best By’ dates carrying 30 days fromthe date of packaging although repackaging is also allowed. As discussedunder the above section entitled ‘Background to the Invention’ using theequivalency of one of the two eggs allowed in each dozen to be Grade Beggs as causing illnesses when consumed as infrequently as threeseparate servings annually by the general population that one egg of twoeggs allowed to be mis-marked in each dozen consumed on average onceevery four months by the general population in less than hard-cookedform likely would cause illnesses costing on average $20,000. eachtotaling $19.2 trillion annually.

Significantly, using only the annual costs of the two referenced sourcesof illnesses from chicken eggs absent of several additionalillustrations available such would provide for an avoidable public costof $37.2 trillion annually which looking at it from one perspective onlyis adequate to retire the national debt, pay for national healthcaretogether with major medical for all members of the population, fund overa two year span the unfunded debt held by the country and double themilitary budget for homeland security needs as well as gainingpreparedness for homeland defense through increases regarding same notonly to the military budget but also to provide protection against suchother risks likened to and including cyber warfare.

As an analog to the above the level of pasteurization required for theinactivation of viruses is materially greater than that of salmonella asfound within the Se strain. Consequently the level of inactivationachievable under the new art of pasteurization described herein isaccomplished through the novel method of intermittent applications ofheat and its denial enabling total inactivation of the targetedpathogens together with performing such within a uniquely securedenvironment remaining pure from the initiation of pasteurization throughto its completion which result is achieved under the novel art claimedherein. Those features are new and unique to the art being described,and their use in combination with each other is equally unique. Whenemployed together those two primary areas of inventiveness as applied toin-shell chicken eggs provide for a total inactivation of the targetedpathogens regardless of whether the level of inactivation is higher orlower than that required for current pathogens which may over timebecome more heat resistant and require still greater levels of heat fortheir inactivation whether bacterial or viral.

The isolated environment for pasteurization provided by the new mediumcontains specifically designed features which in combination enable theunique achievement and maintenance of a level of protection which istotal. That totality is provided by the isolation of the subject eggsfrom all external exposures to contamination or recontamination fromcommencement through conclusion of pasteurization containing the new artwhich enables total inactivation of targeted pathogens. That achievementtogether with the induced ambient cooling of the subject eggs posthaving received a protective sealant while still within the protectiveenvironment as provided by the unique design of the medium provides fora new protocol that uniquely eliminates well in excess of 1.0 millionillnesses annually through the inactivation of the pathogens bothhistorically and forecasted to continue to cause those illnesses ateither the chronic level experienced or in a magnified level stemmingfrom a pandemic.

For further clarity the subject eggs during pasteurization are placedwithin a medium containing unique features which include the eliminationof all risks of preexisting contamination and all risks ofrecontamination for reason that the pasteurization process bothcommences and terminates within a uniquely-designed medium that providesfor certainty that the integrity of the sealed and controlledenvironment which through automation is continuously cleansed andremains secure from inception of pasteurization through to completion.The protocol employed from conception to completion of pasteurization isperformed within an isolated environment that is not breached until theeggs are fully pasteurized and fully protected against recontaminationthrough application of a food-grade sealant to their shells and onlythen are the subject eggs allowed to be exited from the describedsecured environment.

No known reliable resolution to the issues of total inactivation ofsalmonella in all strains and viruses in all of their strains as may beor come to be found within chicken eggs except through hard-cooking thesubject eggs or cooking at the least to a level which included materiallosses of natural flavor and raw characteristics i.e. functionality andaesthetics excepting for the new art described and claimed herein isknown to exist.

The new art claimed herein not only provides for full inactivation ofboth salmonella as a pathogen and viruses also as a pathogen but alsouniquely provides for a level of inactivation which is statisticallyqualified to be considered complete. Through the new discoveriesdescribed herein which include both the medium for pasteurization andthe uniquely high levels of pasteurization the ability to achievecomplete inactivation of targeted pathogens is of particular importanceto the 150.0 million persons identified as having compromised immunesystems.

Further to the above under the new art and separately from thepasteurization protocol referenced above as being and integral part ofthe new art but of equal novelty and importance the environment of thepasteurization medium has been isolated as new art and together with thebenefits of new and innovative protocols employed provides for the risksof recontamination to be eliminated.

The referenced areas of new inventiveness described and claimed hereinfulfill the need to destroy viral contamination as currently found ormay continue to evolve and to become found within chicken eggs. Thethreat to public health from viral contamination of chicken eggs isconfirmed by the scientific community as being real, present and alreadyto have occurred in the years spanning 2009 and 2010 which in the UnitedStates caused 12,000 deaths and infected more than 60 million people.Further threats of a pandemic are confirmed by test results from studiesidentifying certain virus strains having evolved into more deadlystrains which enable or carry with them strains of Avian Influenza thathave the ability to be transferred from human-to-human either by directcontact or through the air. Those mentioned abilities of the new virusstrains to transfer illnesses from human-to-human have laid thefoundation for a pandemic to spread more rapidly and widely due to theirability to transfer from human-to-human, but in the absence of such easeof transfer nonetheless will impact upon the health of millions.

Through current reports delivered by the scientific community within2013 a collection of scientists concluded that the evolution of viralstrains enabling human-to-human transfer of the influenza virus capableof causing a pandemic already has occurred and is continuing to evolveinto a form with increased deadliness stemming from the H5N1 virus asone of several viral sources which in the case of the H5N1 already isresponsible for international deaths ranging from Europe to the FarEast. The forecast that the evolution into still more deadly strainscontaining even greater ability to be transferred from human to humanare confirmed by on-going studies resulting in forecasts from theinternational scientific community which opines that it is only a matterof time that viruses will continue to adapt in a manner which willexpand their current ability already only intermittently achieved totransfer illness from human to human which if continued to progress willgive cause for the already forecasted pandemic to occur. The WorldHealth Organization (WHO) is monitoring the surrounding circumstancesand has confirmed that the mentioned Avian Influenza-caused pandemic ina materially greater proportion will occur, and it is only a matter oftime as to its arrival. That forecast has been reinforced by viralcontamination of chicken flocks within the United States during thespring of 2015 giving cause for the slaughter of tens of millions ofchickens carrying viral contamination whose source is related to theH5N1 virus.

The scientific community agrees that the migration of humans as well asthe migration of birds will enable rapid transfer of the virus whichalso will enable the speed of the spread of illness to be massive andglobal in scope.

No record has been uncovered which confirms the quantity of illnessnumbers caused by the use of cool, dirty or contaminated rinse waterused on eggshells produced for either liquid product or in-shell egg enduses although the science teaching the benefits of the use of warmerwater for rinse has long been known and recommended. Notably when lowertemperatures are employed for rinse water as used within the UnitedStates to cleanse chicken eggshells having a warmer internal egg contentthe cooler water employed will aid in causing contamination to enterco-mingled, recirculated or repackaged eggs than when the rinse watertemperature is warmer than the internal egg temperature when applied. Infurtherance to the above contamination is both magnified and spreadwithin the contents of a chicken egg when the quality of the eggs ispoorer as caused by extended age and increased levels of contaminationas may be aided in the proliferation and spread of contaminants from thecontaminated wash water employed. Notably, at least within the UnitedStates it is common practice to allow known-to-be contaminated chickeneggs stemming from an environment of uncertainty of age and thetemperature at which the subject eggs were stored to be co-mingled withfresh eggs whether in-shell or liquid egg product in their end use andif pasteurized at all the allowable level to claim pasteurization is 5logs as measured by Se. Globally scientists have confirmed that a 5-loglevel of inactivation of Se as contained within a chicken egg exceedingmore or less 5 days from date of lay will multiply into levels ofcontamination requiring far greater levels of inactivation than thatwhich a 5-log inactivation level provides.

With notable pertinencey the original science contained a 10-log levelof inactivation of salmonella as found within chicken eggs which wasrelaxed to accommodate the economics of egg producers over the healthbenefits to the public.

Since the year 2013 the US-FDA and the US Department of Health and HumanServices have been working with foreign companies located in Canada andFrance in testing vaccines which are intended to be useful in protectingthe public from the H5N1 virus which is recognized to be the leadingpotential source of a pandemic associated with Avian Influenza. However,since the H5N1 virus continues to evolve the vaccine development too isevolving and is being stored for potential need was such to occur priorto the research being in its final form. The lack of a finaldetermination of the strain or substrain of the virus requiring avaccine adds to the benefits to be derived from a pasteurizationprotocol for chicken eggs which eliminates the viral pathogens givingcause to the vaccine development as such relates to the portioncontributed by contaminated chicken eggs which for 40 years or moreannually have been recognized to be the leading source of illness from afood source.

It is known that viruses are more heat-resistant than are bacteria. Thenew inventiveness described and claimed herein addresses thevulnerability to heat as a vehicle for inactivation of both bacteria andthe more heat-resistant strains of viruses which exist or may come toexist within the described threat to public health resulting from theirevolution which in the end gives cause for the already forecastedpandemic to occur.

In regard to the inactivation of viral strains as may be found withinchicken eggs which would give cause to a pandemic as potentiallyenhanced by human-to-human transfer resulting from instances already ofrecord the new art contained within the inventiveness described providesfor the inactivation of the more heat-resistant viruses over that ofsalmonella strains as found within chicken eggs through employment ofnew formulas enabling inactivation which enable the application of heatwithout consequential damage to any one of the primary ingredients of achicken egg. Those elements are identified as the outer albumen whichconsists of the thinnest substance in its composition. The secondelement consists of the inner albumen which has a more dense substancethan the outer albumin and is visually identified when an egg has beenopened by being the second most inward of two concentric circles and ashaving a greater depth than the abutting outer albumen. Flowing inwardfrom the inner albumen toward the yolk and abutting the yolk is thethird element of the three albumens associated with the chicken egg. Itis identified as the vitelline membrane. The vitelline membrane isattached to the egg yolk which has a fatter composition and when the eggis opened it visually is seen to be elevated above the other twomentioned forms of albumen.

The rate of heat transfer and heat loss follows the order and thedistinguishing physical elements within an egg as described above whichalso provides for differing rates of heat gain and heat loss consistentwith each element in that same order. Since the outer albumen containsthe thinnest substance and is located closest to the eggshell and theheat transfer employed for pasteurization or preheating as employedprior to pasteurization is applied first to the eggshell, the heatsupplied whether through a water bath which is not preferred or a sprayor a mist of water directly to the exposed eggshell which is preferredmay include purified air as an equal alternative to a spray of water inall of its forms which can be preheated and enhanced by enhancing agentssuch as ultraviolet or other enhancing agents approved by agencies ofjurisdiction for food-grade uses as a precaution against contaminationor recontamination as applied to the exterior of the eggshell in amanner which enables all of the exposed shell to receive effectivelyequal exposure to the described water or air in any referenced formwhich may include air separately from water in combination withsupplemental purification agents previously noted. Those protocols arefollowed by programmed temperature changes both promptly and totallyprovided to all of the exposed eggshells. The water temperature changesare programmed to be at a temperature setting above 128° F. forpasteurization to occur. The temperature setting for the purposes ofthis illustration may be 132.5° F. which is subject to variousmodifications as is recited in greater detail under the ‘DetailedDescription of the Invention’. Excepting the outer albumen the totalpasteurization cycle provides for all elements of the egg to maintain atemperature at 128° F. or above throughout the pasteurization cycle asenabled by their rates of heat transfer and heat loss which are not thesame but do contain a tolerance level of differentiation which providesfor similarity of exposure to heat and its denial without damage to anysingular element of the egg. The one exception recited is found to bewithin the application of heat and its denial as applied to the outeralbumen which is the least dense element of the egg in its substance andis also the speediest in responsiveness to heat gain and loss. As aresult of the analysis and discovery of the varying characteristicsfound between the different elements contained within a chicken egg asto their distinguishing differences it has been learned that thosedistinguishing differences create variables between the elements as suchrelate to differing rates of heat transfer, heat loss, heat toleranceand potential coagulation. The new art takes advantage of theabove-described distinguishing differences between the mentionedelements of the egg and converts that new knowledge into a vehicle forproviding egg safety through pasteurization at levels of inactivation oftargeted pathogens which may be new, unique and provide equal levels ofstatistically total safety from both salmonella and viruses to theconsuming public and most particularly the nearly 45% of the populationwhich is identified by the Government as having compromised immunesystems a/k/a members of the sometimes-identified High Risk Group. Allof the above is provided without consequential loss of the functionalcharacteristics of a raw egg as well as substantially maintaining theaesthetics of a raw egg. Notably, the nutritional values of the subjecteggs are retained which is in direct contradiction to all alternativeprocesses which employ in part or in whole sterilization.

A significant element within the new discoveries is the importantdiscovery concerning how to convert the composition of the outer albumentogether with its location being nearest to the exterior of the egg intobeneficial use with regard to controlling heat transfer that wouldenable higher levels of pasteurization to be achieved without materialcoagulation of any one element of the chicken egg. It was discoveredthat the rates of heat gain and heat loss as being more rapid within theouter albumen was convertible into becoming the control point of whenheat application could be terminated to avoid coagulation of the outeralbumen. The discovery of the application of heat being controlled atmultiple temperatures within time frames dictated specifically andsingularly by the characteristics of the outer albumen is a criticalelement for achievement of successful pasteurization which totallyinactivates targeted pathogens that previously never has been availablewithout damage to the raw characteristics of a chicken egg. Thediscovery described regarding the outer albumen enabled the otherelements contained within the egg i.e. inner albumen, vitelline membraneand yolk to continue pasteurization without damage to their rawcharacteristics because of their respectively lower rates of heattransfer due to their denser compositions and more remote locations tothe heat source than that of the outer albumen. Those discoveriesenabled a formula to be created that was adaptable to log levelstargeted and adjusted to accommodate such things as the impact of theegg size among other factors known to those skilled in the art whichinclude but are not limited to seasonal changes in egg water content,effects of altitude to the subject eggs together with other influencesupon the chickens' environment which collectively or separatelyinfluence the duration of heat application to perform pasteurization toa selected log level which provides for total inactivation of thetargeted pathogens without damage to the raw characteristics of thesubject chicken eggs. All of such has been made available by thediscovery of the use of the outer albumen together with its uniquedifferences in its speed in reacting to heat gain and heat loss asmeasured by its relative comparison to all other elements within thechicken eggs being slower but differing from each other in those sameareas which include speeds of heat loss and heat gain. The studies ofthe uniqueness described of the outer albumen as related to the speed ofheat loss and heat gain enabled the creation of a new and unique formulacontaining variables which accommodate the differing characteristics ofeach element recited as being within a chicken egg and to employ thatnew knowledge into the creation of a new formula for pasteurizationwhich resulted in the inactivation of the targeted pathogens whetherbacterial or viral uniquely absent of damage to the raw characteristicsof any element of the chicken egg. Thus the discoveries contained withinthe new art include the control of the application of heat and itsdenial as taught by the discovery of the uniquely different sensitivitylevels to heat as found within the outer albumen and the management ofthat new knowledge through applied practice levels of pasteurizationperformed through the applications of heat together with intermittentdenials of heat to the subject chicken eggs which also provides for theavoidance of coagulation of the outer albumen which enables theachievement of a minimum of a 10-log inactivation of targeted pathogensthat includes all strains of salmonella as commonly found within chickeneggs together with the inactivation of viruses which currently areevolving and providing a threat of a pandemic conveyed in part throughthe viral contamination of chickens and their eggs. The preferred formof the described art includes induced chilling to lower the temperatureof the outer albumen more rapidly when the intermittent chilling isprogrammed. Such provides for tighter controls over the variablesoccurring between the different elements contained within a chicken eggduring pasteurization which in the end can be tailored to produceefficient timeframes that convert into lower cost of product for thepublic to benefit from along with the benefits of avoidance of largequantities of costly illnesses. By doing such in the manner outlinedunder the ‘Detailed Description of the Invention’ section the protocolprovides for levels of pasteurization as measured in pertinent logs tothe targeted pathogen to achieve total inactivation of the targetedpathogen selected. Notably, the achievement of inactivation of targetedviruses automatically inactivates all strains of salmonella known to bepresent within chicken eggs. Although each element described to be foundwithin the chicken egg is not identical in heat tolerance enoughflexibility exists within each element to allow for the targeted logreduction to occur without damage of consequence to any one elementgiving cause for its loss of raw characteristics were overshooting of atargeted log reduction to a modest extent to occur involving anyparticular element containing a need for additional exposure to the heatapplied for targeted inactivation. For further clarity the new artdemonstrably has a flexibility through adaptation of adjustments to itsheat and cooling cycles to expand its capabilities to accommodate theinactivation of new strains of either viruses or bacteria which wouldrequire additional logs over those logs currently required forinactivation of either or both those named pathogens and their currentderivatives. As described in detail above the outer albumen is the oneexception. However, due to the outer albumen's unique characteristics ofhaving accelerated rates of heat gain and heat loss over all otherelements of the egg and using those unique characteristics collectivelyas the point of control of the protocol employed tests confirm thattargeted log reductions providing for the total inactivation of virusstrains as found to be present within chicken eggs are available evenwere such targets to exceed 10 logs as measured by viruses. The new artcontains an important discovery of how to avoid damage to the fragileand heat-sensitive outer albumen as caused by heat. Such is accomplishedthrough the use of the intermittent applications and denials of heatwhich provides for the benefit needed to avoid damage to the outeralbumen while at the same time providing for continuous anduninterrupted pasteurization of each of the other elements containedwithin the chicken egg as made available through their slower reactiontimes to the application of heat and its denial as provided by theirgreater densities. Such programmed applications and denials of heatcontinue until the targeted log level for the inactivation of thetargeted pathogen has been achieved. Notably as applied to bothsalmonella and viral contaminations the US-FDA originally set a loglevel of ‘4’ for inactivation of Se as found within chicken eggs whichunder the Rule of 2009 became a 5-log inactivation of Se for both liquidegg product and in-shell chicken eggs.

For further clarity under all of the described applications whosedetails are further discussed under the ‘Detailed Description of theInvention’ section that section addresses such matters as exposure timesat different temperatures and most significantly addresses security fromrecontamination which has never been achieved on a reliable basis underall prior art.

Notably as discussed earlier but worthy of repetition the new artcontains two separate primary discoveries. When employed in tandem theyprovide for the achievement of total inactivation of targeted pathogenswhich for the first time includes viral contamination as found withinchicken eggs as described above as well as notably and uniquelycontaining a protocol which effectively provides for the totalprotection against recontamination. The one exception to the aboveregarding the presence of a virus within chicken eggs relates to theH3N1 which when present within a chicken egg gave cause for protectiveactions to be performed which were the same as those performed whensalmonella was found to be present within chicken eggs. What occurredwas that the flock would be destroyed, the eggs would be diverted intopasteurized liquid egg product and the hen house together with allassociated equipment would be cleansed before use by a new flock.Notably the H3N1 virus was treated in the same fashion as salmonella ifemployed within liquid egg product i.e. for decades co-mingled andpasteurized to a 4-log level using salmonella as the measure when infact the virus long has had greater resiliency to heat than doessalmonella. That issue was compounded as a threat to public health bythe inadequacy of the 4-log pasteurization of liquid egg productemploying Se as the targeted pathogen which was neither the mostheat-resistant strain of salmonella nor was it inactivated at 5 logswhen cell counts frequently exceeded the capabilities of inactivationemploying a 5-log protocol for reasons discussed in greater detailherein before. Significantly, under the Rule of 2009 the log level forsalmonella pasteurization was raised to ‘5’, and official references tothe H3N1 virus disappeared.

Through success of the mentioned inactivation of the pathogens as foundwithin chicken eggs such will provide one major avenue for the speed andspread of the pandemic to be blocked by the new inventiveness discussedherein which effectively enables the total inactivation of the targetedviruses or bacteria through the employment of heat while at the sametime preserving the chicken egg as a needed food source. Such is enabledby the application of heat to the targeted chicken egg to a level neverbefore achieved which provides clinical levels of safety while at thesame time retaining the nutritional and raw characteristics of a chickenegg and preserving its continued use as a food ingredient at a time ofnecessity when food that is safe is in short supply.

Notably and significantly within the United States alone thepreservation of chicken eggs as a reliable and safe source of food wouldprovide for a supply of 7.260 billion dozen eggs produced annually as asource of both highly nutritional and safe food once processed under thenew art provided for pasteurization of in-shell eggs which in part canbe diverted post-pasteurization to satisfy the need for liquid eggproducts in their various elements i.e. whole eggs, whites only, etc.Separately the new art which enables total inactivation of pathogensthrough pasteurization within liquid egg product and in-shell chickeneggs at 5 logs as measured by Se enables 2.1 billion dozen of 7.260billion dozen to be diverted into liquid egg products which already willhave been inactivated at twice the level of what currently is requiredby the US-FDA under the Egg Safety Rule of 2009. Such would eliminatethe costly risks to public health caused by the current level ofinadequate pasteurization of liquid egg products being provided to anunsuspecting public.

In the course of destroying viral contamination which requiresmaterially greater heat to provide inactivation than does salmonellabacteria which also is found to be a contaminate within chicken eggs theherein described and claimed new inventiveness effectively inactivatessalmonella which has materially less resistance to heat than do virusesas currently found or may come to be found within chicken eggs.

Were the transfers of illnesses from human to human to occur throughviruses whose new deviations already have been confirmed to exist asreported by the scientific community and reconfirmed through manyscientific reports of record generated by the international scientificcommunity agreement exists regarding a forecast that the foundation fora pandemic must be treated as already being present. Such validates theforecast as provided by WHO as recited herein before.

Notably the new inventiveness claimed herein not only provides for thetotal inactivation of salmonella as found within chicken eggs throughgreater applications of heat than previously considered practicable butalso provides for the inactivation of viral contaminates found to bematerially greater in their heat resistance when compared to salmonella.The fulfillment of the elimination of the cited risks notably includesthe important elimination of the risk of illnesses and the spread ofillnesses from human to human as may be caused by virally-contaminatedchicken eggs when such eggs are consumed less than hard cooked unlesspasteurized to a minimum of a 10-log level of inactivation as applied toviral strains. Although most viral strains which may be found withinchicken eggs are known not to transfer illness from human to human therisk of a pandemic caused by the potential of new and already existingviral strains enabling human-to-human transfer of illnesses moreaggressively require pasteurization to succeed in the inactivation anddestruction of viral contamination with certainty. Since the scientificcommunity has confirmed both the presence and the risk of a pandemic asstemming from Avian Influenza prudence dictates that instead of waitingfor a more substantial pandemic to occur over that of the recited one of2009-2010 an appropriate step would be to block in advance a majoravenue of its spread by providing pasteurization to chicken eggs whichunder new art completely eliminates risk of illness from both virusesand salmonella while at the same time preserving the purity of the eggstogether with their raw characteristics and nutritional values. The newart also is flexible within its protocol. Such enables consumerprotection from mutations of existing pathogens whether viral orbacterial and new strains of both groups continuing to develop whichwould provide for their ability to materially increase the required heatto provide for their inactivation while at the same time preserving boththe nutritional and raw characteristics of the subject eggs. All of theabove additionally provides for the preservation of public healththrough protection of a basic food source as enabled by the new andunique technology described and claimed herein. Notably, the newtechnology uniquely provides for prevention from recontamination or newcontamination as may occur from the unprotected environment found to bepresent post-pasteurization through to consumption.

From the above-discussed ability to inactivate viruses as found withinchicken eggs it should be noted that in the absence of that ability thetransfer of illnesses from human to human increases the threat to thepublic of a pandemic as conveyed in material part by the contaminationcarried through the presence of viruses within chicken eggs. That threatwhich is global in part can be eliminated through the statisticalinactivation of the viruses as found or may come to be found withinchicken eggs through the employment of totally destructive quantities ofheat to rid the targeted eggs of viral contamination which at the sametime inactivates all strains of salmonella which prior art has failed toaccomplish on a commercial scale. Whether or not another pandemic occurswhich may be more massive in its scope as was the case in 1918 the scopeof illness as found from consumption of contaminated chicken eggs evenon its current level as found through bacterial contamination togetherwith the current new threat from viral contamination whethertransferable from human to human or not warrants the benefit of safetyfor a public within which nearly 45% belong to a high risk group.

The described destruction or inactivation of the less heat-sensitiveviruses targeted requiring materially greater heat for theirinactivation than is required for the inactivation of all strains ofsalmonella as may be found within chicken eggs is enabled through newinventiveness providing for the methodology to manage the quantity andspeed of heat transfer as determined from the teachings learned from thecharacteristics now determined to be unique to the outer albumen. Thosediscoveries concerning the thinner composition of the outer albumen ascompared to the denser inner albumen and still denser vitelline membraneand yolk have provided teachings resulting in important newinventiveness based upon the knowledge gained regarding thedifferentials in heat transfer to and from the four mentioned elementsas taught by the rate of heat transfer differentials and applying thatnew knowledge into a formula which enables an overall greater exposureof the total egg to heat than previously believed to be availablewithout loss of the raw characteristics of the targeted eggs while atthe same time achieving levels of destruction of viruses as measured inquantities of logs applicable to viruses necessary to enable their totalinactivation. Since no strains of salmonella as found within chickeneggs require the quantity and duration of heat for their destruction asdo virus strains the total inactivation of salmonella in all of itsstrains as found within chicken eggs automatically occurs through theprotocol employed to inactivate any targeted virus strain which may bepresent.

The differential in heat tolerances as measured in logs as applied toboth the H3N1 and the H5N1 viruses as compared to all strains ofsalmonella are confirmed by the USDA's own laboratory. Under the newprotocol based upon the mentioned discoveries concerning theavailability of greater application of heat a 12-log level ofdestruction of bacteria (salmonella) as found within chicken eggs isavailable to be utilized instead of the prior protocols employing moreor less 5 logs which were marginally useful in the destruction ofcertain strains of salmonella as found within chicken eggs but notablynot all strains nor all levels of contamination likely to be found toexist in part or in whole from date-of-lay through date-of-consumption.To those reasonably skilled in the art including those within Governmentagencies of jurisdiction it is common knowledge that no commercialenterprise previously has successfully managed to processsalmonella-contaminated or virally-contaminated subject chicken eggscontaining the H3N1 virus to a log level as measured by Se materiallygreater than 5 logs without negatively impacting upon the functionalityand the aesthetics of the chicken egg while retaining its nutritionalbenefits together with its raw egg functional characteristics. Notablythe mentioned 12-log level of Se inactivation is adequate to providetotal inactivation of Se including the more heat-resilient strains ofsalmonella as found within chicken eggs as previously neither was usednor was recognized in the calculations employed. Were viruses tocontinue to evolve and to gain more heat resistance than 10-logs asapplied to viral contamination the new protocol enables through itsability to apply heat intermittently and with pre-selected quantities ofredundancy to inactivate materially higher log counts of virus cells asnecessary to achieve total inactivation. The disparity for theinactivation between viruses and bacteria as found within chicken eggsis confirmed by the USDA through its Research Laboratory which has beenusing for study purposes up to a 2-log level of differential forinactivation of the H5N1 virus to equate to the less heat-resistantstrain of Se. Example: A 5-log level of inactivation of the H5N1 virusequates to up to a 7-log level of inactivation of Se as per Dr. DavidSwayne of the USDA Research Laboratory located in Athens, Ga.

Notably the new inventiveness through its redundant features alsoincludes the cyclical and intermittent application of heat whichincludes a correspondingly cyclical denial of heat as its most criticalfeatures to enable the protection against coagulation of the outeralbumen while at the same time enabling the continuing pasteurization ofthe denser inner albumen and still denser yolk to achieve the initial10-log targeted inactivation of viruses when present. The mentionedcyclical feature of applying intermittent heat to the moreheat-sensitive outer albumen as previously explained enables not onlythe achievement of the mentioned targeted 10-log inactivation of virusesbut also provides for the ability to expand the inactivation of thoseviruses to higher log levels which satisfy the need to inactivate stillmore heat-resistant strains of viruses were such needs to occur. Thecyclical feature of the new art provides for and relies upon theredundancy of the application and denial of heat to the outer albumen.That feature enables the more heat-sensitive outer albumen to avoiddamage by taking advantage of its more rapid heat transfer through thespeed in which it benefits from heat discharge to avoid damage throughcooking and loss of its raw egg characteristics as well as itsnutritional values. Through fluctuation of the application of heat andthe intermittent denial of heat to the outer albumen within apredetermined range and frequency the outer albumen only will be exposedto the heat providing intermittent pasteurization while the other denserelements of the egg can be programmed to benefit from continuouspasteurization as provided from staying within the temperature rangewithin which pasteurization occurs i.e. 128° F. and higher.

For improved understanding of this feature of new inventiveness whilecarrying out the mentioned redundancy in the application of heatproviding for the protection of the outer albumen from heat damage it isnecessary to control through the use of intermittent transfer of heatthe quantity of heat being received by the outer albumen. That controlis achieved by the intermittent denial and application of heat whichbenefits from the least dense composition of the outer albumen whichprovides for more rapid heat transfer than do other ingredients of theegg more specifically identified as the inner albumen, vitellinemembrane and the yolk. The intermittent denial of heat usually can beperformed more efficiently for both control purposes and improvedeconomic purposes by use of induced chilling as well as overshootingwhen heat is applied.

Inherent to the processing of chicken eggs as anyone reasonably skilledin the art would know adjustments will be required to the length andintensity of heat exposure from the pasteurization protocol employed asis influenced by differing egg sizes, seasonal changes in water content,increases in levels of contamination caused by material differences intime lapses from date-of-lay to processing together with other elementswhich give cause to refinements to the art employed as caused by localconditions when employed. Those identified variables once learned willbe included into a formula which automatically programs the number ofcycles of time and variable temperatures required for a specific batchof chicken eggs to be pasteurized to a specific log level plus theduration of each element of the cycles described to achieve thebeneficial results of total inactivation of the targeted pathogenswithout consequential negative impact to the raw characteristics of thesubject chicken eggs. The described protocol provides for statisticallytotal inactivation of all current and anticipated pathogens that maycome to exist within chicken eggs which already have and will continueto place the public health at high risk of illnesses. That describedhigh risk to the public is the result of pathogens in the current formsof viruses and bacteria continuing to evolve in the course ofself-protection which in the end requires higher levels ofpasteurization for their inactivation. Such is further complicated bythe results of misinformation caused by human error as is demonstratedby underestimating the level of pasteurization required to totallyinactivate salmonella within chicken eggs as followed by an equallyflawed reliance upon prompt, deep and continuous refrigeration fromfarm-to-table as being both practicable and effective in the firstinstance. In the second instance the reliance upon deep refrigerationprimarily was the result of the failure to achieve the mentioned 10-logsof inactivation of salmonella through pasteurization without damagingthe raw characteristics of the liquid egg product. That resulted in areduction of the level of pasteurization as measured in logs to 4 logswhich practice was continued through 2009 at which time the US-FDAaltered it from 4 logs to 5 logs which is where it has remained throughthe present.

Further to the above if the base level of inactivation of salmonella isflawed at the 5-log level and as previously explained the ratio betweeninactivation of salmonella as measured by Se and the currentinactivation level of viruses as now found to exist within chicken eggscarries with it a 2-log differential the whole premise of what level isto be targeted to inactivate either or both salmonella and viruses usingsalmonella inactivation as the measure becomes uncertain and opens thedoor for greater risk of illnesses for the consuming public through theuncertainty that the targeted pathogens in fact have been inactivated.That uncertainty is answered within the original level of inactivationof salmonella provided under the Egg Products Inspection Act of 1970within which the inactivation of salmonella as found to be presentwithin chicken eggs was determined to require up to a 10-log level ofinactivation to enable co-mingled liquid egg product to be free fromsalmonella contamination.

In 2013 unpasteurized egg cartons changed their ‘Best By’ datesmaterially and changed that date to be thirty days. With onlyinterrupted refrigeration available from farm to table in actualpractice a more than adequate timeframe is provided for a lethalcontamination count to occur within the subject chicken eggs capable ofcausing illness or death to the consumer particularly if that consumerbelongs to one of the high risk health groups. Such is supported bystudies which confirm the rate of multiplication of the referencedpathogens to achieve quantities present within a single egg whosenumbers reach hundreds of millions of cells in a matter of days usingonly a base contamination level of 3 salmonella cells at time of lay.Notably the referenced number of days enabling multiplication ofsalmonella cells into counts measured in millions are materially less innumber than the quantity of days found between the date-of-lay throughthe published date identified as ‘Best By’ as currently displayed on eggcartons. That seemingly available and modest misrepresentation as to the‘Best By” date provides for an equivalency of anywhere from one week tosix weeks added to the age of the eggs before consumption. The timeframefrom lay to consumption as applied to either interrupted deep chilling,high levels of salmonella contamination present at time of processing,resulting from repacking with new dates as currently allowed incombination or separately are not cured by deep chilling which at bestif continuous without interruption retains the initial level ofcontamination which already may be lethal. Hence, pasteurization claimsemploying less than 10 logs as applied to Se for either liquid eggproduct or in-shell chicken eggs whether pasteurized or raw misleads thepublic into a clear path of illness and even death fromsalmonella-caused illnesses. The above problems recited are furthercompounded by the content of reports provided by the Legal Department ofthe USDA carrying a date of November 2012 within which the frequency ofcontamination reported by the US-FSIS as being one egg in 277,000 wascorrected and reconfirmed to be one egg in 20,000 as being contaminated.The US-FSIS also through prior studies treated the mentioned one egg in20,000 not only as being contaminated by salmonella but also as givingcause to an equivalent number of illnesses. Notably and separately, astudy of experts identified as NERO recently published a troublingreport which included the currently-allowed uses of between three (3) tofour (4) Grade B eggs to be included in a dozen of so-mark Grade Achicken eggs. Also according to NERO the mentioned Grade B eggs were notonly substandard to the extent that they should have been taken off themarket but also may have been carrying with them a level of salmonellacontamination which exceeded the capabilities of current arts ofpasteurization targeting 5 logs of Se as the level at which undercookedeggs were safe to consume whether in liquid form or within a shell. Inseparate reports Grade B eggs are defined as containing high levels ofsalmonella contamination. Further, studies confirm that the practice ofcollecting unsold eggs which may or may not have had the benefit ofprompt, deep and uninterrupted refrigeration continues to be allowed tobe repackaged and to receive a new ‘Best By’ date which whencontaminated to begin with may by the time of consumption enable acontamination level exceeding one hundred million cells of salmonella tobe present in each egg.

Notably and of significant importance under the protocol of the new artdescribed and claimed herein the management of the exposures totemperatures and their duration as applied to each of the internalelements of a chicken egg during pasteurization utilizes thedifferential in densities of the outer albumen with those of the inneralbumen, vitelline membrane and yolk in order to take advantage of thedifferential in the rate of heat transfer within which each elementdiffers. The newly-discovered beneficial uses of those differentials inthe speed of heat transfer to and from the named elements as arranged intheir natural order within which the inner egg is composed and itsapplication into a beneficial formula never before reported as utilizedenables the achievement of higher levels of pasteurization as measuredin logs without damage to the subject eggs in terms of aesthetics,functionality and nutritional benefits. That new and novel achievementprovides for complete statistical public safety from illnesses caused bycontamination of chicken eggs through either or both viral and bacterialsources. Such is accomplished in material part by using the time lagbetween the vitelline membrane and the yolk as compared to the time lagrequired for heat transfer as found within the inner albumen and to agreater extent the outer albumen which consists of substances that varyin their density giving cause to the need to apply or deny heat intemperatures and durations at rates tailored to those preexistingconditions. Notably the denser substances require extra time over thethinner outer albumen to gain or to lose temperature depending uponwhether heat is being applied or denied. Because the vitelline membraneand yolk respond materially slower to heat change than does the outeralbumen the outer albumen which consists of the least dense substance ofall elements contained within an egg reacts with greater speed to heator its absence than do those mentioned denser elements which respondmore slowly to the application of heat and its denial albeit atdiffering rates consistent with their mentioned natural order. Notablymost prior art if not all when attempting pasteurization is limited inthe log achievement to the level of inactivation of Se through the needto avoid coagulation of the outer albumen as may be followed by each ofthe other elements recited. Thus, the new art uniquely employs withinits protocol the outer albumen as the basis of control for the amountand duration of heat applied for pasteurization through the novelbenefits provided from intermittent application. Under the new art thevariances involving heat loss and heat gain are computed and convertedinto a formula to satisfy the differing requirements for totalinactivation of pathogens through adjustments of the variables outlinedand discussed concerning the elements contained within the compositionof chicken eggs and the impact upon the subject eggs caused by thosevariables during any pasteurization protocol employed in order toachieve the new and unique levels of inactivation of pathogens while atthe same time preserving the raw benefits of the targeted chicken eggs.The referenced variables include the physical characteristics of thesubject chicken eggs, their environment and their targeted level ofpasteurization together with the specifics of pathogens targeted as suchrelate to heat transfer.

The new art provides for expansion and contraction of the base protocolemployed to accommodate not only the peculiar needs through heatinactivation of different pathogens without damage to the rawcharacteristics of the subject chicken eggs but also incorporatesflexibilities within the base protocol to allow for natural featuresimpacting upon the time and temperature regimes employed as would beknown to those skilled in the art and as further influenced by materialdifferences in egg water content, altitude as affecting heat transferrequirements, egg size and in the end the targeted log reduction throughthe employment of formulated time and temperature exposures. Foremphasis and certainty of clarity the outer albumen is the first interms of time lapsed to react to heat gain or loss. The compositiondensities as contained within the vitelline membrane and yolk givescause for them to be the slowest in terms of time lapsed to react toheat gain or loss. The understanding of the natural order of thementioned separate elements within the subject eggs together with theunderstanding of their composition and relative rates of heat transfertogether with their differing speeds of reaction to temperature changesas now understood under the new inventiveness described herein has beenconverted into a practical formula targeting the inactivation ofpathogens as opposed to the inadequacies of prior art to provide suchresults. The new protocol which uniquely provides for absoluteinactivation of targeted pathogens as found within chicken eggs isbetter understood through the collection of facts only learned andapplied under the new art as now recited in detail for clarity ofunderstanding.

Under prior art the achievement of a 5-log inactivation of Se was set bythe US-FDA in 1997 at the request of this inventor. Achievement of thatlevel of pasteurization as set by the US-FDA enabled a claim to beprovided to the public that the product was ‘PASTEURIZED’ which in turnclearly implied safety. It since has been learned and confirmed byagencies of jurisdiction that the mentioned 5-log level ofpasteurization frequently has been inadequate to inactivate not onlysalmonella strains but also viral strains which since have become asubstantial new threat to public health.

The current art claimed herein uniquely succeeds in protecting the rawfeatures as found within the outer albumen of a chicken egg to provideprotection of that substance from coagulation which otherwise would notbe useful as applied to uses typical of raw eggs.

Notably, the new art for the above-cited reasons employs the outeralbumen as the control point whereas prior art utilized the yolk as thepoint of measure to prove that the targeted 5-log inactivation of Se hadoccurred. In the absence of protecting the outer albumen fromcoagulation through mentoring and controlling its heat gain and losswithin pre-determined temperature parameters as impacted by both thenature of the source of the heat applied and the measured impact uponeach element described within the composition of the subject chickeneggs together with adjustments appropriate to accommodate localconditions no improved log levels of destruction or inactivation ofrecord is known to be available before the discoveries of such asreported and claimed herein. Absent of the now-described new art noprior art existed which was capable of protecting the public from themore heat-resistant viral contamination while maintaining the rawcharacteristics of a chicken egg and its safety to be consumed as abasic food source when less than hard-cooked. Those benefits from thenew art discussed and disclosed herein reduce the severity of the chaosexpected and forecasted by the scientific community to occur in the nearterm in the form of a pandemic caused by Avian Influenza a/k/a the ‘BirdFlu’. Even in the absence of a pandemic viral contamination togetherwith its capability for human-to-human transfer already established as amatter of fact as having occurred in 2009-2010 in the United States ishere to stay.

Under the above-described circumstances a dependency of relying upondeep chilling of the chicken eggs only to retard the pace ofmultiplication of salmonella into lethal quantities estimated to be 2weeks in an ambient environment became relied upon. That reliance wasmisplaced because the achievement of immediate and continuous deepchilling particularly at times of natural disasters as compounded byfrequent and forecastable numerous interruptions to the distributionsystem occurring at any point in time from farm to table is unavoidablein practice.

The above-recited issues not only create risks to an uninformed publicbut also create additional risks when misinformation from officialsources goes unattended. That misinformation is not limited to butincludes two primary examples among others. In the first instancecartons containing non-pasteurized egg carry a statement entitled ‘SafeHandling Instructions’ which in size of print and language employedleaves the vast majority of the public uninformed as to its existence.That referenced ‘Safe Handling Instructions’ by authorization of theUS-FDA is not required to be displayed on cartons carrying pasteurizedeggs. In the second instance were eggs to be pasteurized at 5 logs theterm ‘PASTEURIZED’ can be displayed as allowed by the US-FDA. Notably,it has been common knowledge that no strains of salmonella as foundwithin chicken eggs are reliably and fully inactivated at 5 logs whichprior to the enactment of the Rule of 2009 the art practiced for liquidegg product allowed for a 4-log reduction of Se to display the term‘PASTEURIZED’ on liquid egg product although the record confirms thatlong prior to 2009 the inactivation of salmonella in multiple strainscommonly found within chicken eggs as used in liquid egg productrequired a 10-log inactivation as required by the agency ofjurisdiction. Historically, the initial unpublished reduction from 10logs to 4 logs for liquid egg product carried with it the authorizationto label the product as ‘PASTEURIZED’. From a public consumerperspective that term implied safety which stemmed from a long historyconcerning milk. Nonetheless the mentioned Rule of 2009 raised thepasteurization level from the mentioned 4 logs for liquid egg product toonly 5 logs. That new level of pasteurization represents the most recentrequirement as measured in Se logs in the evolution of pasteurization ofchicken eggs as overseen by the agency of jurisdiction. The new Rule of2009 specifically provides for the inclusion i.e. co-mingling ofso-labeled and separately identified highly contaminated chicken eggswith ordinary run-of-the-mill eggs to be utilized within liquid eggproduct. The mentioned enablement of allowing known-to-behighly-contaminated chicken eggs to be co-mingled into liquid eggproduct by reasonable extension or interpretation of the mentioned Rulealso would enable eggs similar in their level of contamination to remainin their shells and to be pasteurized to 5 logs and sold as pasteurizedin-shell eggs. That practice would wreak havoc upon the public's healthand more particularly members of risk groups approximating 150.0 millionpersons having compromised immune systems which according to the US-FDAare at high risk of contracting illnesses from less than hard-cookedchicken eggs. That risk is further elevated by the new risk ofcontamination of chicken eggs from viral sources. Such remains to be thecurrent status of the pasteurization of chicken eggs as provided to thepublic and its reliance upon its Government oversight.

Significantly, as a result of the above-cited information it is notablethat although no change in policy has occurred regarding the continuedomission of the display of ‘Safe Handling Instructions’ on cartons ofpasteurized eggs the US-FSIS has confirmed that a 5-log pasteurizationprotocol of Se does not succeed in the inactivation of all salmonella asmay be present within a contaminated chicken egg. The achievement of a5-log inactivation of Se as set by the US-FDA continues to qualify theegg cartons to be labeled as ‘PASTEURIZED’, to display a USDA Shieldindicating appropriate inspection has occurred and concurrently allowsfor the elimination of the copy on raw in-shell egg cartons entitled‘Safe Handling Instructions’. Curiously the same 5-log inactivation ofSe has since been discredited by the Centers for Disease Control andPrevention (CDC), the US-FSIS, the scientific community and the USDAResearch Laboratory as being both unreliable as applied to safety andinadequate to provide total inactivation of all strains of salmonella asmay be found within chicken eggs. Further concerns of the inadequacy ofa 5-log inactivation of Se result from studies conducted within thescientific community which confirms that Se is not the mostheat-resistant strain of salmonella as found within chicken eggs nor isSe as found within chicken eggs primarily the result of ovariancontamination. Notably non-pasteurized in-shell chicken eggs havecontinued to be required to display the mentioned ‘Safe HandlingInstructions’ which reference risks of bacterial contamination althoughall agencies whether domestic or international continue to be both awareand alarmed that the real and present threat of materially greatermagnitude is not bacterial contamination of chicken eggs alone but nowincludes aggressive and more threatening changes within viral groupswhich currently are found in ever-growing numbers within chicken eggsincluding the year 2015 reports as being present within domestic flocksin the United States. Such has given cause for egg prices to rise byapproximately 50% per dozen and gives cause as well to the destructionof tens of thousands of laying hens contaminated with viruses akin tothe H5N1.

The new risk of a pandemic has a prior history. As an important andtimely anecdote the inadequacies of the above-described regulatoryissues became critical to the United States public's health in 2009-2010when a pandemic sickening some 60 million persons and killing some12,000 persons occurred in the Untied States resulting from a deviationfrom the H1N1 virus which remains non-specific as to the original hostvirus. That experience confirmed the presence of the health risk tohumans caused by viral contamination to birds and their eggs aspreviously forecasted and continued to be forecasted by both thescientific community and the World Health Organization (WHO). Thecontribution provided under the new art described herein for publicsafety is timely and contains negligible added cost to the public.

Separate but resulting from the above-reported pandemic of 2009-2010 theHealth and Human Services agency (HHS) has endorsed and provided acommitment for some $150 million in funding to an independent firm toprovide for the research and development of a vaccine which is intendedto provide the public with protection from the potential arrival of theinfluenza described as the Bird Flu. In the end, as mentioned hereinbefore, the scientific community finds consensus that the current threatof Avian Influenza will again blossom into a pandemic through theprimary vehicle of birds migrating and spreading viral contamination toother birds which include chickens and their eggs.

With the oncoming threat caused by new and more heat-resistant viralstrains over bacterial strains as found only until recently to be thesole contaminant to chicken eggs with the exception of the H3N1 virusthe inadequacy of all prior art to consequentially exceed a 5-loginactivation of the bacteria identified as Se without loss of the rawcharacteristics of the subject eggs has become critical not only to boththe egg product industry and to the in-shell egg industry but also tothe public which already has been forewarned of the potential for aglobal pandemic stemming from Avian Influenza and has just finishedexperiencing a pandemic ending in 2010 caused from avian sources whichinclude both chickens and their eggs as well as the arrival of the H5N1virus in chicken flocks within the United States.

Under the new inventiveness described herein an answer to theinactivation of all forms of salmonella at all levels of contaminationtogether with separate or concurrent inactivation of more heat-resistantviral strains without loss of either functionality or nutritional valuesuniquely is enabled. That enablement is performed under the new andclaimed art described which not only provides for higher log levels ofinactivation without negative impact upon the aesthetic and functionalcharacteristics of the egg as compared to those of a raw egg but alsoprovides for the inactivation of all pathogens which may be present. Ithas been determined that the new art readily achieves a 12-log level ofSe inactivation which converts into a minimum of a 10-log inactivationof the viral strains containing greater heat resistance than salmonellastrains. Notably, the new art due to its unique cyclical application ofheat at predetermined programmed intervals and the denial of heat atcoordinating intervals adjusted to provide total inactivation oftargeted pathogens and the characteristics peculiar to the batch of eggsbeing processed reliably enable the effective total inactivation of bothviral and bacterial contamination of chicken eggs which is both new andunique to the egg industry. Such provides the public for the very firsttime with clinically safe eggs which can be consumed by risk groups andthe general population in all traditional egg preparations without riskof illnesses.

Notably and of material importance the new art not only achieves thementioned 10-log inactivation of aggressive and dangerous pathogenicviral strains which are becoming increasingly present within chickeneggs but also contains within its protocol which is unique to the newart the ability to materially expand that protocol through repetition orredundancy of the individually tailored elements within the protocolemployed to accommodate the differing characteristics of the subjecteggs being processed along with the targeted level of inactivationrequired to provide certainty that inactivation of the targetedpathogens is total. That novel level of flexibility as provided underthe new art described above allows for needed adjustment of the protocolto accommodate differences between egg batches. Those differences givecause to adjustments within the base formula employed which includeaccommodation for differing egg characteristics such as size and watercontent as two examples but also includes the characteristics anddiffering levels of heat resistance as found within targeted pathogens.That knowledge provides for adjustments to a base computerized formulaprogrammed-to-be readily adjusted to accommodate the needs forsuccessful performance of the described protocol. The described protocolemployed to provide pasteurization to a level of inactivation ofpathogens present within chicken eggs is performed within an equallynovel medium to the pasteurization protocol described above which asdescribed herein below provides for pasteurization from inceptionthrough completion to be performed without risk of survivingcontaminants post-pasteurization or recontamination before any exposureoccurs from a potentially contaminated environment as found external tothe medium.

The new art further protects against pathogenic recontamination whetherviral or bacterial which has occurred under all prior art either throughinadequate pasteurization or faulty protocols preventing againstrecontamination which frequently but not exclusively have been found tobe enabled by concentrations of airborne contaminants resulting frompasteurization of large quantities of chicken eggs within their shellseffectively exhaling pathogenic viruses and bacteria in sufficientquantities to overcome negative atmospheric precautions throughprotocols employed during pasteurization. That phenomenon enablesrecontamination of the subject eggs when internal contraction of thesubject eggs en masse occurs during ambient cooling. The cooling createscontraction of the internal egg which draws in air through its exposedshell pores. The resulting air current provides a suitable avenue forthe airborne contaminants to flow into the eggs through their exposedeggshell pores which gives cause for recontamination of eggs previouslycontaminated but more significantly gives cause for eggs to becomecontaminated when nonesuch contamination previously existed. Under thenew art those risks of recontamination have been resolved through thecreation of a new and unique pasteurization medium containing numerousunique features and protocols which provide for a secured environment aswell as protection against exposure to recontamination as enabled by theredundancy of arts which inactivate pathogens when present whileblocking and treating all avenues for the entrance of new pathogens fromthe external environment surrounding the secured environment of the newand unique medium for pasteurization of the subject eggs as described ingreater detail herein under the section entitled ‘Detailed Descriptionof the Invention’.

In Summary: Under the new inventiveness claimed herein thepasteurization temperature selected is applied to the shells of thesubject eggs in the preferred form of a spray of water. The spray ofwater readily can be converted into different densities which include amist and in all cases will contain a food-grade antibacterial agent asthe preferred method over that of a water bath which is viable undercertain new controlled conditions as discussed herein but is notpreferred. The mentioned preference of a water spray to perform thetransfer of heat and its denial while performing pasteurization ofin-shell chicken eggs results from the recognition of its superioradaptability to fluctuations in temperature as called for from protocolemployed using equipment and controls which enable prompt changes inwater temperatures which conform with the precision required to satisfythe need for changes in water temperatures, improved control over ratesof heat transfer and rates of heat denial for predetermined durationswhich also include the needs for and the benefits from both the promptand consistent application of heat transfer whether added in itsemployment or denied in its employment as called for within the uniqueprotocol for pasteurization described. Those improved controls areparticularly important to avoid even the slightest risk of over cookingany element of the subject eggs being pasteurized since the level ofinactivation achieved never has been performed before and a lack ofeither reasonable precision and consistency of the characteristics of araw chicken egg particularly as applied to the sensitivity of the outeralbumen to heat causing coagulation can occur on very short notice oronly from what may seem to be a modest deviation of the protocolemployed. The predetermined durations of the elements within thecyclical applications of heat and its denials conform to theinventiveness under discussion which allows for the applications of heatand the denials of heat to be customized into a programmed protocolwhich provides for specific durations of heat applications and theirdenials to the shells of the eggs during pasteurization. Theinterruptions to the applications of heat and their denials are adjustedin their durations to reflect the needs for protection of in-shell eggsagainst heat damage.

To aid in the understanding of the uniqueness of the protocol employedtogether with its equally unique achievements to inactivate targetedpathogens without damage to the raw characteristics of the subject eggswhich contain a variety of variations the protocol employed within thenew art as programmed and described and claimed herein accomplishes suchthrough a preprogrammed application of heat and its denial specific tothe characteristics of the batch of eggs being processed forpasteurization. Each variation of the protocols employed includes thecycling of the application and denial of heat to the subject chickeneggs through employing a unique process which consists of the raising ofthe temperature of the subject eggs to the targeted pasteurizationtemperature and holding them there for a preprogrammed duration which isfollowed by lowering the temperature of the subject eggs back to theoriginal temperature of the subject eggs at the time of the beginning ofthe described process. The timeframes for all elements of the describedprotocol are characterized for these descriptive purposes to be cyclicalin nature. Each cycle is tailored to provide relief from sustained heatbeing applied to the outer albumen through preprogramming theapplication of heat as followed by the application of chilling ingreater intensities of each of such for the outer albumen than the otherelements of the subject chicken eggs. Such is done in a manner and to anextent which enables the outer albumen to have limited durations ofexposures to heat during the heating cycles while at the same timeallowing all other elements not requiring the same relief from heatcausing damage to their raw characteristics to continue to receive heatfrom uninterrupted pasteurization albeit the pasteurization temperaturesapplied will be fluctuated to accommodate the level of pasteurizationtargeted to accommodate the specific characteristics of the individualelements of the subject eggs being processed without giving cause todamage from excessive heat to any one element contained within thesubject eggs. Throughout the pasteurization protocol employed during thetimes equilibrium has been reached between the yolk and the water spraytemperature or its optional counterparts when employed a holding timeproviding for approximately 1 log or slightly more occurs before thetemperature is reduced. That protocol is repeated until the targetedlogs for total inactivation of the targeted pathogens has beencompleted.

As discussed earlier the outer albumen through its accelerated rates ofheat gain and heat loss dictates the temperatures employed along withthe duration of a cycle as well as the number of cycles to be employedto achieve the targeted level of inactivation as measured in logsspecific to the targeted pathogen. Such is the result of a discoverythat the composition of the outer albumen provides for more rapidtransfer of heat and more rapid results from heat being denied.

That knowledge under the new art is applied in a unique manner whichconfirms that such can be used constructively within a protocol forpasteurization of chicken eggs as is now contained within the new art asdescribed and claimed herein. The new art enables the use of protocolswhich succeed in providing for the total inactivation of both bacterialand viral contaminants when found to be present within chicken eggs. Theart employed to inactivate targeted pathogens is both unique andeffective in achieving log levels never before achievable without damageto the raw characteristics of the ingredients contained within a rawchicken egg and most particularly the outer albumen. Those discoveriesenable higher log levels of inactivation of targeted pathogens to beachieved by formularizing the critical control points of coagulation ofthe outer albumen and applying that formula into a protocol whichthrough preprogrammed applications of heat and its denial reflecting thediffering characteristics found within a given batch of chicken eggsallows for the outer albumen to escape heat damage through applicationsof induced chilling on a programmed basis which enables the outeralbumen to be protected against heat damage while at the same time allof the other denser substances as found within chicken eggs similarlybeing heated or cooled are allowed to continue pasteurization withoutinterruption by their internal temperatures being preprogrammed toremain above 128° F. In the end the protocol employed allows repetitionto the described applications and denials of heat which provide for theachievement of the targeted log level required for the inactivation ofthe targeted pathogens. The number of cycles required to achieve thetargeted pathogen inactivation are the result of the tolerance levels ofthe outer albumens' tolerance to heat as dictated by the characteristicsof the specific batch of chicken eggs. Notably, each batch processedcontains eggs of similar size as measured by weight. Their relativelycommon size dictates their common level of tolerance to heat whichenables pasteurization under the new art to be achieved withoutreduction of the raw characteristics of the subject eggs. Such allowsfor the conversion of the application of heat and its denial into apreprogrammed protocol which includes the new art of applications ofcycles which apply controlled amounts of heat and controlled amounts ofcooling to the subject eggs to the extent dictated by the previouslydescribed specifications of the eggs being processed at pre-selectedtemperatures and durations which are programmed to achieve totalinactivation of targeted pathogens while protecting both the rawcharacteristics and nutritional benefits of the subject eggs. Thosecycles cumulatively will equate to the achievement of the targeted loglevel of the outer albumen while the denser elements of the subject eggsin their natural order as found within a chicken egg will achieve thesame targeted log level of pathogenic inactivation without falling below128° F. Heat damage to the denser substances is avoided by lowering thetemperatures but only to an extent that does not interrupt thepasteurization occurring. In the end the targeted log level is achievefor all elements including the outer albumen which has escaped damagefrom heat exposure by programmed retreats to temperatures below 128° F.The denser elements of the subject chicken eggs will not be chilledbelow 128° F. because of the protection against heat damage providedfrom their varying higher densities which allow for the continuation ofpasteurization at differing rates due to their differing densities whichin each case is slower than that of the outer albumen to achieve thepasteurization level as measured in applicable logs. Although the denserelements carry with them differing rates of heat transfer in the endtheir margins of differences are not enough to warrant altering theapplications of heat employed to the specific characteristics of thesubject batch of eggs being subjected to high log counts ofpasteurization enabling total inactivation of the targeted pathogens.Such is confirmed through test results which have taught that once thetargeted log level at an applied temperature for pasteurization has beenachieved the various elements continue to have a tolerance for heatbeyond the targeted log level. That additional tolerance for heat allowsfor a level of flexibility which enables a modest overshooting of thetargeted log level to be employed for each element contained within thechicken egg to achieve the targeted log level for the inactivation oftargeted pathogens.

Notably, the outer albumen temperature is impacted by its higher ratesof heat gain and heat loss which give cause for the art employed toprovide the outer albumen with obtaining protection from heat damagethrough finding refuge provided from the intermittent applications ofheat and its denial as interrupted by induced chilling which togetherprovide for a haven within which the outer albumen is protected fromheat damage by providing solely it with periodic temperatures below 128°F. The described outer albumen protocol employed for its protectionresults from the discovery that the natural order contained within thecomposition of the subject eggs parallels the changes in the densitiesof those same substances. Hence the applications and the denials of heatfollow an order which in the end achieves the targeted result ofpasteurization with only minor differences in the logs achieved to eachof the denser elements as nature has provided that order to be i.e.least dense as found within the outer albumen resulting in the mostrapid transfer of heat gain or heat loss, followed by the inner albumen,followed by the vitaline membrane and in the end the yolk. The yolkbeing the most remote and the densest element within a chicken egg cantolerate the heat being applied outside the shell being received lastand can tolerate it being the last to loose its heat. That natural orderof heat gain and its disbursement from outside the shell inwards and itstransitioning between each of the elements once completed is reversedthrough applying a selected form of chilling which may be induced orambient that when completed carries with it the outer albumen beingbelow 128° F. and each of the other elements within the subject chickeneggs continuing pasteurization and carrying with them temperatures at128° F. or above. Once the outer albumen has reduced its temperature tothe targeted temperature below 128° F. the cycle for pasteurization isreinitiated. To avoid heat damage to any one element the cycles arerepeated for predetermined intervals which end with the achievement ofthe targeted log reduction without damage to any one element as foundwithin the chicken eggs because the inventiveness has been taught by theorder provided by nature that the transfer of heat inwards will followthe order created by differing composition densities of each of theingredients found within chicken eggs. That discovery combined with thefurther discovery that the outer albumen composition providing formaterially greater rates of heat transfer both as measured in gain orloss enabled the new and unique protocol to be formulated as adjusted toaccommodate already discussed variations within eggs and the variationsrequired to inactivate pathogens providing that the specialcharacteristics as found within the outer albumen are allowed to governthe protocol employed which in the end provides for a new and uniquevehicle to achieve inactivation levels of targeted pathogens whicheffectively are total as applied to those found within chicken eggswhile at the same time preserving the nutritional and physicalcharacteristics of a raw in-shell chicken egg.

Through the novelty of the discovery of how to use the vulnerability toheat damage of the outer albumen to an advantage focus was made upon theresults of experiments performed upon the rate of heat transfercontained within the outer albumen which lead to new knowledge as to itsrates of heat gain and heat loss. The knowledge gained lead to theassociation of the mentioned speed of transfer as influenced by thelocation of the outer albumen as compared to other elements within thechicken egg consisting of denser substances identified as the inneralbumen, vitelline membrane and the yolk. It further was discovered thatthose other named elements shared two common characteristics. They weremore remote from the heat source than was the outer albumen which wassurrounded by the eggshell to which the application of heat forpasteurization was applied in the first instance. In the second instancethe composition of each of the other elements contained varying higherdensities in their composition and carried with them a location withinthe egg which followed an order of least dense to most dense. Thatsequence in the same order accepted heat being applied and dischargedheat when cooling in reverse of that order. Briefly stated andsummarized the fragility of the outer albumen caused by its thinnercomposition resulted in a higher rate of heat transfer both in gain andloss which in each case is reflected by a greater rate of speed inchanges of temperature than all other elements contained within the egg.Those more rapid transfer characteristics of the outer albumen whetherthrough temperature gain or through temperature loss are enhanced by itsclosest proximity to the heat source which also serves as the vehiclefor disbursement of heat during periods of heat loss which under the newprotocol employed enabled the intermittent application of both heat andits loss to occur on a programmed basis to avoid damage to the outeralbumen during pasteurization under the new art which increasesmaterially the quantity of heat applied to perform its improvements topublic safety through achieving the total inactivation of pathogensfound within chicken eggs. The described programmed applications of heattogether with the programmed denials of heat providing for totalinactivation of targeted pathogens through materially higher levels ofpasteurization resulted in the discoveries employed which included theunique enabling protocol of the cyclical application of heat and itsdenial that has become the basis of a new and unique program forpasteurization enabling the benefits derived from total inactivation oftargeted pathogens. That program avoids damage to the outer albumenthrough the mentioned cyclical application of heat and its denial whichprovides a new and unique capability to perform pasteurization withoutdamaging the contents of the subject egg to any consequential levelwhile at the same time and for the first time has enabled totalinactivation of viruses and bacteria which now give cause for the publicfor the first time ever to be free from illnesses caused by less thanhard-cooked chicken eggs. The achievement of not only the totalinactivation of all strains of salmonella as found within chicken eggsbut also through the same art containing the unique ability to beexpanded through the ability to extend the redundancy of the applicationof the protocol employed which includes the application of heat to thechicken eggshell and the denial of heat to those same shells atpreprogrammed intervals for preprogrammed durations resulting fromcalculations derived from science performed regarding heat transferrates, egg size variables, logs targeted as measured by the targetedpathogen for its total inactivation, induced chilling for efficiencypurposes as well as measured overshooting of the targeted pasteurizationtemperature for efficiency purposes collectively form the basis fromwhich the time and temperature protocol containing essentiallyfluctuating temperatures are derived which in the end accomplish theinactivation of the targeted pathogen while preserving the rawcharacteristics of the subject eggs along with their functional andaesthetic resemblances to those of raw chicken eggs. The duration of theapplication of heat to the eggshells, the intermittent reduction intemperatures applied to the subject eggshells to preserve the rawcharacteristics of the internal egg and the reinitiation of the targetedpasteurization through both the water temperature and the internal eggtemperature reaching equilibrium with the pasteurization temperatureselected are influenced by certain variable conditions discussed hereinbefore that include the different elements of the subject eggs' whichcontain differing rates of heat transfer. Once equilibrium has beenreached by and between the targeted pasteurization temperature to beemployed with all elements of the subject eggs the protocol forpasteurization to a pre-selected log level of inactivation commences.For illustration purposes the selected targeted pasteurizationtemperature utilized may vary within a range of six degrees or more, butfor these illustration purposes the temperature will be 132.5° F. Thevariations as referenced reflect the results of extraneous influencesupon the time required to achieve the targeted log reduction of thetargeted pathogen selected which is influenced by such factors as eggsize, chicken diet, water content, altitude impacts upon temperaturesemployed for pasteurization and other factors commonly known to thosereasonably skilled in the art separate and apart from thecharacteristics contained within the targeted pathogens. Afterequilibrium has been reached between the targeted temperature of 132.5°F. and all elements of the subject chicken eggs the subject eggs areheld at that temperature until an additional 1-log level more or less ofpasteurization has occurred in addition to the portion of a log thatoccurs from the internal egg temperature rising from 128° F. to thementioned selected targeted pasteurization temperature which is followedby water in the form of a spray or other recited means to employ heattransfer to the subject eggs as recited herein before which may causetemperatures employed to vary but in principle the key features of theart form for pasteurization under the new art i.e. the cyclicalapplication of heat and its denial together with a new and unique mediumwithin which security is provided to achieve unadulteratedpasteurization will be employed. Those variances range from a rinsetemperature which is below 128° F. but above the ambient temperature ofthe subject eggs. The rinse temperature first affects the outer albumenbecause of the combination of its location as being nearest to the shellwhich provides total exposure to the temperature of the medium i.e. inthis preferred selection the temperature of the preferred spray oftreated water and the composition of the outer albumen being thethinnest in substance of all the substances contained within a chickenegg carry with it the most rapid rates of heat loss and gain. It isimportant to note that the cumulation of logs towards the targeted logreduction not only includes the cumulative logs resulting from theholding times of the temperatures for pasteurization when equilibrium isreached between the internal temperature of the subject egg and thetargeted pasteurization temperature i.e. as used here to be 132.5° F.but also includes the cumulative logs achieved during the times wheretemperature is rising and declining to and from the targetedpasteurization temperature. Those cumulative log reductions achievedfrom the combination of both the temperatures increasing and decreasingto and from the targeted pasteurization setting of 132.5° F. become amaterial part of the total targeted log reduction achieved through tothe time frame required for pasteurization. That time frame can beshortened in consequential part by the employment of overshooting apasteurization temperature while going upwards and employing inducedchilling while the temperature is going downwards. The net result whenemployed aids in increasing production while lowering overall costs. Inthe absence of employing a conventional heat source to the preferredspray water employed applied at predetermined temperatures, in apredetermined sequence and under conditions referenced as above for thedurations described the source of the heat applied directly to thesubject eggs can be provided in various form which include but are notlimited to a stream of a fluidized substance, microwaves travelingthrough the air as well as the use of other sources of energy as isillustrated by ultraviolet or the employment of heat lamps which alsoprovide heat to the air to which the subject eggs are exposed. Suchprovides for a substitute to water with air as the preferred mediumwhich may also include focused sunlight that create concentrations ofheat conveyed through a secondary medium or directly to the subjectchicken egg recipients. For the purposes of this document and the artcontained herein the selection of a water spray in its various formswhich include a mist or shower are the preferred options to be employedfor the transfer of heat and the reduction of heat into the subjectchicken eggs. The described protocol is dependant upon refinements inthe field resulting from a variety of factors likely understood by thoseskilled in the art with knowledge concerning chicken eggs which wouldinclude but not be limited to such things as egg size, water content andother extraneous matters which are more fully discussed elsewhere inthis section.

The discovery of how to use those differences in a novel manner toprovide an urgently needed broader spectrum of pasteurization has beenenabled by the flexibility of the protocol employed which satisfies therequirements described concerning the adjustments to the application ofheat and its denial without causing consequential damage to the rawcharacteristics of the subject egg while at the same time providing forfull and reliable protection against pathogens which already are presentor may come to be present within chicken eggs.

As an illustration of the differing rates of heat transfer as foundwithin different elements contained within chicken eggs research resultsconfirm that the relative acceleration of heat transfer which ischaracteristic of the outer albumen over that of the denser substancesfound within the eggs consisting of the inner albumen, vitellinemembrane and yolk reveal that a spray water temperature of 137.5° F.applied to eggshells for five (5) minutes generates an outer albumentemperature of 131.1° F. and a yolk temperature of 115.2° F. whichconfirms the differing impacts of heat upon the outer albumen as beingboth pertinent and confirmatory to the conclusions reached within thenew art as such relates to the heat transfer characteristics containedwithin the outer albumen. The ingredients of the above comparativeanalysis of heat transfer to other elements within an egg confirms thatthe increased sensitivity to higher heat and heat denial as beingcharacteristic to the outer albumen over those of other elementscontained within the chicken egg. Upon further research that pattern wasreconfirmed and equilibrium between the named elements occurred shortlythereafter. Further experiments now indicate and confirm that a similarrate of heat loss occurs when either ambient cooling or induced chillingis applied. Those observations and their confirmations lead to using thefragility of the outer albumen as applied to heat gain and heat loss tobe employed in a constructive manner which lead to the intermittentapplications of heat and its denial through which achievement of greaterlog levels of inactivation were enabled to totally inactivate targetedpathogens while preserving both nutritional and raw characteristics ofthe subject in-shell chicken eggs.

For further clarity to better understand the novel protocol discussedabove the art employs a repetitive protocol for the application anddenial of heat which is described as being cyclical in nature as isconfirmed from records demonstrating the difference in the time spansbetween the least dense element as represented by the outer albumen andthe most dense element as represented by the yolk when heat is equallyapplied to those elements for the same duration. What was learned wasthat the outer albumen in a matter of five (5) minutes achieved atemperature differential with that of the yolk approximating 15° F.which reconfirms the foundation of facts necessary for the ability toachieve log levels for the inactivation of targeted pathogens as foundwithin chicken eggs through intermittently fluctuating the applicationof heat and its replacement with induced chilling in a manner whichprimarily interrupts the quantity of heat being applied to the outeralbumen which otherwise would give cause for its coagulation and loss ofraw characteristics.

In summary, studies performed during the research of this portion of thenew art confirm that the slower rates of heat gain and loss as foundwithin the denser inner albumen, vitelline membrane and yolk can be usedto advantage through proper management of heat gain and loss as appliedto the thinner outer albumen through utilizing its more rapid speed inheat transfer as expressed through both heat gain and heat loss asenabled by its inherently thinner composition. The discoveries describedand claimed herein contain new and unique phenomena which use thegreater speed of heat gain and heat loss of the outer albumen of achicken egg to a significant advantage which results from its conversioninto a formula that enables the unique ability to achieve the targetedgoal of higher log levels which totally inactivate viruses which alreadyexist and continue to evolve and to provide for a major threat to publichealth when consumed in any form of an egg food ingredient that has beenprepared for consumption when less than hard-cooked.

The above-described advantages are enabled by the new ability containedwithin the new inventiveness to achieve log levels of inactivation ofmaterially more heat-resistant viruses than as found to exist withinsalmonella bacteria. Such now provides certainty that public safety isavailable from inactivation of both viral- and salmonella-contaminatedeggs which prior art statistically never achieved without damaging theraw characteristics of the subject eggs.

Additional to the above-described protocol benefits the followinguniquely enables the total inactivation of viruses currently found orexpected to become found within chicken eggs through achievement of newlevels of pasteurization specifically targeting the inactivation ofviruses which require higher levels of inactivation through exposure toheat for their inactivation than do bacterial contaminants as foundwithin chicken eggs. That achievement not only succeeds in the totalinactivation of salmonella as commonly found to be at high count levelswithin chicken eggs which were not previously achievable in theirinactivation under prior art employing a 5-log level of inactivation butalso under the new art raises the bar of pasteurization to include theinactivation of viruses through the achievement of total inactivation ofall targeted pathogens which prior art neither accomplished aspertaining to salmonella nor attempted as pertaining to viralcontamination for reason that prior art could not reach the log levelsrequired for inactivation of either the pertinent strains of salmonellaor viruses without loss of the raw characteristics of the subjectchicken eggs targeted for pasteurization. Those described inadequaciesunder prior art gave cause for a substitute for inadequatepasteurization to be provided from deep refrigeration which as anyoneskilled in the art would know is dangerously flawed and places at riskinordinate quantities of the public to become sickened. Notably the newart not only provides for the described safety required frompasteurization but also preserves the nutritional values of the chickeneggs which would be lost were sterilization to be used as a substitutefor pasteurization. Were less than total inactivation to be employedagainst any of the mentioned targeted pathogens as provided through allprior protocol for pasteurization current science confirms that the rateof multiplication of those pathogens surviving will overcome any claimof safety provided under any level of pasteurization currentlypracticed. The ability to inactivate both high counts of salmonella whenpresent within chicken eggs along with new and more heat-resistantstrains of viruses now invading chicken eggs as confirmed by theirnew-found presence contain common features for their inactivation whichare provided by the new pasteurization art described herein. Thoseunique features provide for the inactivation of the targeted pathogensthrough the achievement of high log levels as enabled by and containedwithin the described new art that results in public safety as providedby what effectively is the total inactivation of pathogens consisting ofboth viruses and bacterial strains as may be found within chicken eggs.The above unique benefits of the new art preserve the rawcharacteristics of the chicken eggs which include their raw aesthetics,raw functionality capabilities and nutritional benefits. All of theelements of the described new protocol provide for unique benefits topublic health which are enabled by the described equally uniqueintermittent application of and denial of heat to the outer albumenwhich results in the statistical total inactivation of the targetedpathogens that includes all of the viruses and bacteria as are currentlyknown or may come to be known to occur within or upon chicken eggs. Thenew and unique protocol described is complemented by separate andequally new inventiveness as discussed herein below which preserves thebenefits of pasteurization through avoidance of recontamination which byexperience under prior art authored by this same inventor enabledrecontamination to occur from impure air carrying contaminatedsalmonella bacteria post-pasteurization back to the chicken eggshellsand surviving reentry into the subject eggs although the eggshellspost-pasteurization promptly were sprayed with a food-gradeantibacterial agent. The attraction to the exposed eggshells of theairborne salmonella bacteria cells resulted from their escape en massefrom the internally expanding chicken eggs during pasteurization. Uponcompletion of pasteurization albeit to inadequate levels of inactivationthe internal eggs simultaneously contracted which created a current thatdrew the escaped salmonella cells back into the eggshells through theirexposed pores. The timing of that phenomenon together with the quantityof the cells involved overcame the preventive steps employed to bothimprove the negative atmosphere of the pasteurization medium where theeggs were being pasteurized and to drench the eggshellspost-pasteurization with a food-grade antibacterial agent. Thosephenomena gave cause for all of the eggs even those which in thebeginning had no contamination to become contaminated. The criticalpublic health risks caused by both the shortcomings of the level ofinactivation allowable for salmonella and the quantity ofrecontamination enabled by airborne contaminants have been addressed andcured under the new art described herein which also carries with it arequest for protection. Those issues now resolved and addressed asdescribed above under the new art claimed herein represent significantnew areas of primary inventiveness which enable a unique andnever-previously-achieved level of protection against pathogens presentto be inactivated.

The above-described inactivation is ensured to be permanent and completein its inactivation of targeted pathogens because of its unique featureswhich include a new and fully secured medium for pasteurization whichprevents invasion of its environment through a combination of internalsecurity and ingredients uniquely contained within the medium whichenable total inactivation of targeted pathogens to the subject chickeneggs through the provision of a cleansed environment within which thedescribed protocol is employed from the inception of pasteurizationthrough its completion. Those features as contained within the uniquelyprotected environment of the referenced medium are unique and criticalto the above-described elements of the protocol employed forpasteurization as discussed previously herein above within which allpathogens are inactivated to a level which is total. Notably, underprior art no pathogen reliably was inactivated totally under theprotocol employed whether such was for liquid egg product end use orin-shell chicken egg end uses. The problem of inadequate pasteurizationcontinues to give cause for salmonella-contaminated chicken eggs whetherpasteurized to 5 log levels of inactivation or not pasteurized at all tobe inadequate to such an extent that the consuming public is placed inharm's way. Those frequencies of inadequacy to pasteurization are theresult of limitations to the art employed which now has been materiallychanged under the new art described herein enabling the reliable andtotal inactivation of the targeted pathogens to occur. The new artclaimed herein provides for a level of reliability which includes thetotal inactivation of the more heat-resistant pathogens as found withinviruses. Those new benefits are timely for two reasons. In the firstinstance $18.0 trillion annually are being wasted through theconsumption of unsafe chicken eggs as provided to an unsuspecting publicwhich consists of 150 million persons officially considered to bemembers of high risk groups that by definition have higher risk ofillness from all sources including chicken eggs. The mentioned $18.0trillion per annum is for illustration purposes to better understand theneed for reform. That estimate is based upon facts which are treated asboth those of the Government in their origin and are reduced in theirquantity as applied to their application to that of risk groups only. Onor about 2010 risk groups were reported to contain 150 million persons.All of those persons have compromised immune systems. Some illnesses runinto hundreds of thousands of dollars per illness per annum. TheGovernment carries the average cost of illness from chicken eggs to be$20,000. That number is carried in this calculation although it would beobvious to be understated because the cost for care of risk groupmembers frequently involves costs that contain multiple levels overnon-risk group illness costs. The Government also carries 1 egg in20,000 eggs as being salmonella contaminated. The Government knowinglyallows for highly salmonella contaminated chicken eggs to be provided tothe public when pasteurized to a 5-log level of Se. The Government isaware that 5 logs does not cure an egg from being highly contaminated assuch applies to either salmonella or viruses. In part such is confirmedby the Government continuing to report that salmonella-contaminatedchicken eggs are the leading cause of foodborne illnesses in the UnitedStates. That statistic has been persistent annually for a minimum of 20years. There are approximately 8.7 billion dozen eggs consumed annuallyin the United States. This calculation of illnesses from liquid eggproduct as applied only to risk groups employs each member of the riskgroup consuming 6 breakfast-type egg dishes per annum consisting of 1egg each taken from an average annual US per capita consumption of 20dozen. In the second instance the public is lead into believing thatcurrent levels of pasteurization provide safety to less than hard-cookedchicken eggs for consumption while concurrently enabling a variety ofviolations which defy logic as to the claimed safety available throughpasteurization or as more generally provided by unpasteurized Grade Achicken eggs. In part, certain illustrations support the existence ofthose inconsistencies which are both clear and dangerous to anunsuspecting consumer group of which nearly half carry with themimpaired health. As stated herein before a few illustrations of blatantimproprieties continue to occur which include the re-dating andrepackaging of stale eggs, the co-mingling of Grade B eggs to beincluded in cartons marked as containing either Grade A or Grade AA eggsand the enabling of the co-mingling of known-to-be and so-marked to behighly salmonella-contaminated chicken eggs into liquid egg productwhich when pasteurized to 5 logs as measured by Se carries with it nohope whatsoever of consumer safety.

Certain of the matters involved in reaching the new achievements oftotal inactivation of both viral and bacterial contaminants withoutexposure of the subject in-shell chicken eggs to recontamination asprovided through the application of the protocol contained within thenew art includes but are not limited to two primary subject areas asdiscussed below.

Background: Bacterial strains as known to contaminate chicken eggs havegreater vulnerability to heat than do viruses. Since viruses are lessheat-sensitive than are bacteria the level of heat as measured in logsto inactivate viral contamination automatically will inactivate anysalmonella bacteria strains present because of their materially lowertolerance to heat. Notably, prior art employed pasteurization of chickeneggs as measured by the inactivation of salmonella only which employed alevel of inactivation as measured in logarithms (logs) employing a 5-loglevel which since has been shown to be inadequate for total inactivationand materially inadequate to inactivate new threats acknowledged toexist from viral contamination of chicken eggs which require materiallyhigher levels of inactivation than does bacterial contamination.

The pasteurization achievements described herein before were enhanced bystill an equally important additional area of new inventiveness whichwas made available through the discoveries provided by a pasteurizationmedium that overcame risks to public health caused by inadequatepasteurization and at the same time provided protection againstrecontamination.

Notably the above-described art must be employed within the framework ofa fully and reliably protected environment. As discussed in greaterdetail under the section of this application entitled ‘DetailedDescription of the Invention’ a unique and secured facility has beendesigned to provide pasteurization of in-shell chicken eggs to a levelwhich provides the public with a level of statistical inactivation whichis complete while maintaining the substantially raw characteristics ofan in-shell chicken egg. That level of pasteurization is made availablethrough the pasteurization protocol summaries provided hereinabove anddescribed more fully under the section entitled ‘Detailed Description ofthe Invention’.

Description of the Medium: As a primary and unique new area ofinventiveness which complements an additional description of an area ofnew and distinctly different inventiveness involving a uniquepasteurization art which utilizes the intermittent application of heatto the chicken eggs enabling new and materially higher levels ofpasteurization to occur as measured in logs is found within an equallyunique and distinctly separate inventive protocol to be employed withina secured medium which through its novel features protects the subjecteggs from recontamination during and post-pasteurization includingprotection against airborne or contact risks through the eggs enablingrecontamination when exiting the medium post-pasteurization to table.Such is enabled by new art which ensures the preservation of a clean andcontaminant-free environment from inception of the pasteurizationprotocol through its completion which includes the time at which theeggs have received a protective sealant post-pasteurization but prior totheir exit from the secured environment of the new and unique mediumwhich now includes the performance of pasteurization to a levelachieving statistical inactivation of the targeted pathogens throughemployment of the protocol described earlier herein which provides forthe achievement of inactivation without egg damage to its rawcharacteristics through preprogrammed interruptions of heat and itsdenial. From inception through completion of the pasteurization processthe environment of the pasteurization medium is isolated and controlledto provide safety from recontamination. Only after the selected level ofpasteurization has occurred and the eggs have received protection fromenvironmental sources of contamination external to the medium thatprotection is preserved through the application of a food-grade sealantto the eggshells. Only after that eggshell protection is provided do thesubject eggs exit the medium into the unprotected environment outsidethe medium. From that point forward and through consumption the subjecteggs benefit from the total inactivation of the targeted pathogens andare protected from recontamination by the sealant affixed to the shells.As a subsidiary discovery and for further security from processingthrough table a preferred egg carton produced from self-destructivebio-plastic as made from corn will be employed carrying with it a sealedenvironment which contains a continuous application of an antibacterialagent built into the confines of the secured environment as provided bythe carton.

Notably no art for pasteurization of either liquid egg product orin-shell eggs currently provides to the public pasteurized eggs in-shellor in liquid egg product form which provide for the total inactivationof the targeted pathogens whether all strains of salmonella and bothexisting and anticipated strains of viruses while maintainingsubstantially the raw characteristics and the nutritional qualities of araw chicken egg.

Because chicken eggs when laid contain either visible signs of manure ontheir shells or in most cases contain traces of manure on their shellswhich may not be clearly visible and that manure carries with it knowncontaminants which likely include salmonella and viruses the subjecteggs by natural circumstance are unclean at time of lay. Studiesprovided by competent agencies clearly confirm that Se frequently is onthe shells of the eggs as carried by manure at time of lay as are otherstrains of salmonella. Such matters as contaminated feed, rodentdroppings within the feed, unhealthy air, artificial lighting and stressremain a constant plague to the health of the laying hens. Most reportsindicate that salmonella and more particularly Se is found primarilywithin the ovaries of the chicken and is intermittently present withinthe egg post lay. Regardless of the frequency of Se being present withinthe ovaries of the laying hen the contamination of the chicken eggshellat time of lay without question always is exposed to and is contaminatedby manure. Therefore, prior to treatment of the eggs through thepasteurization protocol described herein together with a unique mediumto perform same the subject eggs to be processed require specialtreatment prior to commencement of pasteurization. The special treatmentresponds to the need of the subject chicken egg shells in most caseshaving lost their natural sealant i.e. the cuticle which protects thenewly-laid chicken eggs from external contamination which is mostevidenced by but not limited to hen manure. Within the art it is commonknowledge that the natural sealant has a limited lifespan of only a fewdays. Once the sealant has been lost or reduced all of the subjectchicken eggs are exposed to a variety of sources which have causedsalmonella contamination to an extent which has made less thanhard-cooked chicken eggs to be the leading cause of foodborne illnesses.With the advent of new threats from viral sources the described problemof chicken egg contamination is magnified together with the quantity ofhealth risks associated with such magnification.

The employment of an optional external shower containing anantibacterial agent together with an elevated temperature of the wateris employed and applied through a spray and is made a part of thepreferred protocol to be employed for selected circumstances. Thementioned elevated temperature of the spray is above 128° F. and onceelevated is not to be lowered for reason that the internal egg willcontract and attract the entrance of still greater numbers ofcontaminants. Such rinsing combined with the rinse water which includesa food-grade antibacterial agent is particularly useful to rid chickeneggs of their external contaminants which frequently contain visiblesigns of manure. Such provides a solution to the inadequacies providedunder current practice to employ infrequent changes of the rinse watertogether with infrequent replenishment of the antibacterial agent withinthe mentioned rinse water. Since the rinse water rapidly collectscontaminants carried by the shells of the subject eggs and the life ofthe antibacterial agent contained within the water has a shelf lifefrequently measured to be less than 12 minutes post-co-mingling with thewater one reasonably skilled in the art would correctly conclude thatthe rinse water itself when exceeding 12 minutes without change asfrequently is the case is a major source of contamination of all of theeggs being processed and exposed to the mentioned water. Such risk ofcontamination of all of the eggs exposed to the rinse water iscompounded by the natural sealants of the shell pores at time of laybeing washed away by the mentioned rinse water which in the end createsa conduit through the exposed pores of each shell of each egg to receivethe contaminants contained within the rinse water which may be morenumerous than the salmonella found within the ovaries of chickens at afrequency confirmed and currently reconfirmed to be 1 egg in 20,000eggs. The presence of manure and other contaminants as reported by theUS-FSIS is not infrequent and does contain a public health risk in itsfrequency and ability to spread disease within foods and within kitchenswhich frequently involves the inclusion of either or both chicken eggsand liquid egg products.

Of significant importance to the topic of egg safety each of thefollowing two primary claims of inventiveness stand on their own as maybe useful under certain circumstances but when utilized together enableinactivation of pathogens to a level never before achieved including theabsence of consequential damage to the raw characteristics of thesubject chicken eggs.

Within the above-referenced two primary claims when employed togetherthey enable the performance of pasteurization to levels as measured inapplicable logs which without additives as currently used within liquidegg product achieve a level of total inactivation of targeted pathogenswithout consequential loss of the raw characteristics of the subjectchicken eggs including but not limited to their nutritional benefits aswell as their raw egg functional characteristics.

1. The first of the two primary claims of inventiveness for all in-shellchicken eggs subjected to pasteurization is found within a uniquepasteurization protocol that employs the intermittent application ofheat to the subject in-shell chicken eggs as generated through thepreviously-identified sources of heat generation. For these purposes thepreferred use of a spray or a mist of water at predeterminedtemperatures for predetermined durations in part or in whole may beutilized to provide pasteurization to the subject eggs in their separateelements or as a combination of elements concurrently exposed asdetermined by the source of heat selected. As an added but necessaryfeature to the pasteurization protocol selected the spray or mistemployed will contain a food-grade antibacterial agent which willpreserve the inactivation of targeted pathogens occurring throughout thepasteurization protocol employed. Herein the use of the term ‘spray’will be considered to be interchangeable with the term ‘mist’.

The reference to the application of heat as described above also isdescribed occasionally within this document to be cyclical in itsapplication. That cyclical application of heat and its denial is uniqueto the art described herein. At the peak of the application of heatachieving a targeted temperature for pasteurization that temperature ismaintained throughout the time equilibrium between all elements of theshell egg and the water being applied has occurred and a selected loglevel of inactivation of the targeted pathogen has occurred. Thatinitial level of inactivation is dependant upon extraneous factorsimpacting upon the contents of the egg. Once that phase has beencompleted the preferred spray water temperature is lowered to below 128°F. and held there until such time as the other portions of the in-shellchicken egg have reduced their temperatures to approximately 130° F. atwhich time the application of heat through the preferred water spray isresumed and all elements of the chicken egg commence with temperaturesrising to the initial 132.5° F. as selected to be the preferredtemperature for pasteurization for purposes of this illustration. Afterall elements of the chicken egg have risen to that selected temperaturelevel the temperature is maintained at that level until a predeterminedadditional level of pasteurization has occurred. For purposes of thisillustration which is subject to variables caused by the chicken eggsthemselves the log level achieved at each interval where equilibrium isachieved with the pasteurization temperature selected i.e. 132.5° F. inthis illustration the anticipated holding time at each cycle occurringwill approximate an inactivation of the targeted pathogen by 1 log whichmay reach 1.5 logs under selected circumstances.

For purposes of clarity of understanding the selected pasteurizationtemperature together with the duration of application of thattemperature to the in-shell chicken eggs is not only influenced by thechicken egg characteristics which are general and as previously recitedreflect differences in size, water content and altitude as applied totemperature ranges as illustrations to be considered when adjustingprotocol for pasteurization. Also and of significant importance suchincludes the new dynamics of the outer albumen characteristics as foundwithin its composition that provides for more rapid heat gain and heatloss than each of the other elements contained within the chicken egg ascompounded by its exterior location within the egg as related to theeggshell providing for far greater exposure to external temperaturesthan do the more inward elements of the subject eggs. Once the term ofexposure is terminated as will be learned later in this document thetemperature of the preferred water spray is lowered primarily to protectthe integrity of the functionality of the outer albumen which isperformed to an extent that provides for other elements within the eggto continue to be pasteurized i.e. above a temperature of 128° F. at theend point of its decline giving cause for the use of the term‘cyclical’. The above illustration depicts the application of heatregardless of its source through a unique conveying medium into andthroughout the subject eggs which are composed of substances containingdiffering densities and differing heat sensitivities giving cause forthe heat to be applied intermittently to avoid coagulation of any oneelement within the chicken egg while at the same time recognizing andhonoring the different densities and rates of heat transfer presentwithin each element of the subject eggs. In the end that new and uniqueprotocol enables the benefits of total destruction of pathogens withoutcompromise to the raw characteristics of any one element containedwithin the subject chicken eggs.

Under the described new inventiveness enabling a range of inactivationupward from 10 logs as applied to viral contamination and 12 logs asapplied to salmonella bacteria contamination when found within chickeneggs it is further noted that the novel method of achieving not only thelogs mentioned for both the inactivation of viral and bacterialcontamination as enabled through the cyclical application of heat andits denial to avoid heat damage through coagulation of any one elementthe new art is expandable to still greater levels of inactivation weresuch to be warranted through the arrival of new and greater heatresistant strains of either of the pathogen groups referenced. Foremphasis and clarity it should be noted that the log levels recitedrepresent effectively total inactivation of the targeted pathogens as isconfirmed through published studies provided by the scientificcommunity. Notably, the stated level of total viral inactivation as wellas total inactivation of salmonella bacteria never have been achieved byprior art absent of sterilization or coagulation unless altered byadditives.

With regard to the already discussed cyclical application of heat andits stated novel benefits the new art provides for the preservation ofthe raw characteristics of the outer albumen through interruptions ofthe otherwise constant application of heat during pasteurization. Thatnew art which sometimes is described as the cyclical application of heatas applied to all elements of the eggs achieves log levels qualifying aclaim of total inactivation of all pathogens which may be presentwhether viral or bacterial. Those benefits are made available throughthe intermittent or cyclical application of heat to the subject intactchicken eggs whether their end use is to provide for traditionalservings customary to in-shell chicken eggs or whether their end use isfor conversion into liquid egg product and uses customary to thatproduct. Since the current level of pasteurization for liquid eggproduct may be as little as 5 logs as applied to Se bacteria and underthe Rule of 2009 so-identified eggs containing high levels of salmonellacontamination requiring greater log levels to be inactivated those sameeggs are allowed to be co-mingled and processed into liquid egg productemploying the mentioned 5-log protocol for Se which enables the publicto be sickened from the consumption of the mentioned contaminated eggsand more particularly those members of the public representing riskgroups whose number equates to 150.0 million persons. An obvious benefitto public safety would result from the liquid egg industry eitherdisplaying the ‘Safe Handling Instructions’ on liquid egg product asrequired for non-pasteurized in-shell chicken eggs or convertingin-shell chicken eggs processed to a level of pasteurization achievingtotal inactivation of all strains of salmonella and all strains ofviruses as enabled by the new protocol described herein into liquid eggproduct. As applied to use in liquid egg product the pasteurization ofthe mentioned chicken eggs before conversion into liquid egg productwould require an equivalent facility which provides for a securedenvironment comparable to that found within the medium described hereinbefore for in-shell eggs that will enable conversion of the alreadypasteurized in-shell eggs into liquid egg product while benefiting fromthe materially improved safety gained from total inactivation oftargeted pathogens.

As described earlier under the new protocol the internal eggtemperatures will be brought to equilibrium with the heated water inwhichever form the water to be employed is selected. The cyclicalapplication and denial of heat notably and specifically employsintermittent applications of heat to the subject eggs through thetemperature of the spray water employed as the preferred option to thoseothers previously identified as options which are not preferred. Such isperformed with intermittent denial of heat together with theintermittent application of selectively controlled and treated colderwater which enables a unique achievement of higher log levels ofinactivation of targeted pathogens never before achieved along with thebenefits to public health provided from total inactivation of targetedpathogens present while at the same time preserving both the aestheticand raw characteristics of the subject chicken eggs.

The mentioned cyclical nature of the application of heat and its denialwithin the preferred embodiment of the art will be enhanced bycontrolled induced chilling which will accelerate pre-selected changesin temperatures of the spray water employed for pasteurization to beapplied intermittently at prescribed times and for prescribed intervaldurations as adjusted to conform with the characteristics of the egg andits environment in order to accelerate the total pasteurization time tobe lesser and more affordable as another feature of benefit derived fromthe improved safety achieved from the protocol described. Additionalefficiency of time which converts into lower public cost of product isachieved by overshooting the targeted pasteurization temperature anddiscontinuing said overshooting when all of the content of the subjectchicken eggs reach equilibrium with the targeted pasteurizationtemperature selected to be employed.

Under the new art described herein public safety from salmonellaillnesses derived from chicken eggs is provided through the achievementof the scientifically-confirmed levels of pasteurization for all strainsof salmonella bacteria as may come to be found within chicken eggs.Notably and materially the same art through its expansion capabilitiesa/k/a cyclical heat protocol enables the ability to inactivate virusstrains requiring materially greater heat for their inactivation asmeasured in logs than do even the most heat-resistant strains ofsalmonella. The referenced viral strains are currently known to bepresent within chicken eggs and also are known to be evolving within orco-mingling amongst strains while forming new and more deadly virusstrains which are expected to cause greater quantities of deadlier formsof illnesses to humans together with a new ability to transfer illnessbetween humans which all other strains as found within chicken eggs todate have been incapable of doing. This phenomenon aptly has been namedby the scientific community as the Bird Flu which in part is generatedand transmitted by migratory birds that also spread the virus to humansthrough consumption of polluted water which may cause a separate vehiclefor contamination of in-shell chicken eggs. Notably the already-presentand still-evolving strain identified as the H5N1 carries with it a humandeath rate of 40% more or less among those who have contracted illnessfrom that virus which also has shown a capability to transfer illnessfrom human to human. Current reports confirm that deaths from the H5N1virus have occurred from Europe to Australia and various other areaslocated within the Far East. In further support to the statisticsrecited in 2009-2010 the United States experienced a pandemic resultingfrom a derivative of the H3N1 virus which for decades had mistakenlybeen identified as a virus which when commonly occurring within chickeneggs required a 4-log inactivation to be included within liquid eggproduct. That corresponded with the downward adjustment of Se to 4 logsto avoid coagulation of the pasteurized product. That same virus was thesource of the mentioned pandemic in its derivative form. Notably theU.S.-F.D.A. has omitted references to the H3N1 virus while at the sametime has increased the log level of inactivation of Se from 4 logs to 5logs through the current approval of pasteurization as contained withintheir Rule of 2009.

2. The second of the two primary claims of inventiveness described andclaimed herein consists of a highly secured environment to protect thesubject chicken eggs from exposure to pathogenic contamination once theprotocol selected for pasteurization has been employed. That protectioncontinues until not only the completion of pasteurization enabling totalinactivation of targeted pathogens has been completed but also providessecurity from recontamination through the subject eggs receivingprotection from environmental recontamination post-exit from the securedenvironment of the mentioned medium regardless of the art ofpasteurization selected and employed i.e. use of treated water or othermeans of pathogenic inactivation as recited hereinbefore to be availablefor the protocol selected. Such is enabled through the unique design ofa medium within which pasteurization is conducted.

The unique design of the secured environment of the pasteurizationmedium includes equally unique and separate features whose collectiveingredients provide for an isolated and protected environment withinwhich continuous cleansing occurs which includes the air and the wateras well as the secured environment provided by the medium. That securedenvironment is not violated from the arrival of the subject chicken eggsthrough to and including their exit as being pasteurized to a targetedlog level that totally inactivates pathogens which may be presentwhether bacterial or viral and a protective sealant againstrecontamination has been provided to each egg prior to exit from thesecured environment provided by the medium. The cleansing process withinthe medium employs features which include but are not limited toultraviolet to protect the isolated air within the medium from straycontaminants were such to be present. Also within the described mediumthe preferred protocol includes the use of shower heads appropriatelydesigned and strategically located which employ either a spray or a mistof treated water as needed for the protocol employed which may contain afood-grade antibacterial agent which may be applied within the water orseparately to the subject eggs as called for within the protocol. Theapplication of the controlled duration and programmed heated waterbegins with a drenching of stacked eggs placed within specially-designedflats dedicated for use to ensure that an even and controlled drenchingof each egg being subjected to the new and unique pasteurizationprotocol has occurred. Excepting the end of the pasteurization protocolemployed the water spray will include a food-grade antibacterial agent.Such is performed within the protection provided from the uniquelysecured environment specifically designed and created for thepasteurization medium. The alternate choices of inactivation ofpathogens through that of the use of heated water either wholly or inpart will benefit from the secured environment provided regardless ofthe vehicle for the generation and disbursement of heat to the targetedchicken eggs. As an alternate to the preferred strategically locatedshower heads provided within the unique and secured medium describedabove is a bath which is not preferred due to its containing a greaterrisk of accumulating contamination together with its reduced potentialto promptly change temperatures as efficiently as found within a waterspray or a mist as serviced by the continuous cleansing process featuredwithin the protected environment of the referenced medium. For thosereasons the bath remains open as an option but is not preferred.

Notably, eggs grown off-site most often will contain contamination ontheir shells and also the subject eggs may not have benefited fromimmediate, continuous and deep chilling. Those same eggs may also carrywith them dates of lay which have provided for the known-to-be rapidmultiplication of not only salmonella but also viruses which give causefor a greater need for cleansing the shells and to promptly attend totheir pasteurization to log levels not previously anticipated orrequired by the US-FDA Rule of 2009 enabling a level of pasteurizationof 5 logs of Se to qualify for use of the term ‘PASTEURIZED’ when such a5-log level of pasteurization of Se is known to be inadequate toinactivate all strains of salmonella which may be present at all levelsof contamination.

Although the presence of viral contaminants was known to exist prior to2009 and also known to require still greater levels of inactivation thansalmonella as found within chicken eggs the Rule of 2009 nonethelessallows for a 5-log inactivation of Se to qualify eggs to display theterm ‘PASTEURIZED’ and to abandon the display of ‘Safe HandlingInstructions’ as required on non-pasteurized eggs or their resultingproducts.

Further to the above and as recited earlier in the section entitled‘Background to the Invention’ in a report authored by NERO confirmationof current practices of long prior standing were addressed whichincluded but were not limited to recommendations that the practice ofchanging egg cartons containing unsold eggs into new cartons containingnew ‘Best By’ dates be discontinued. Separately the co-mingling of GradeB eggs which frequently contain high counts of salmonella contaminationwell beyond a 5-log pasteurization protocol's capability to inactivatewas recommended to be discontinued from being co-mingled into Grade Acartons at a ratio of three (3) to (4) four eggs per dozen carrying thehigher grade mark. Separately the US-FDA in its Rule of 2009 not onlymaintained a 5-log inactivation of known-to be and so marked to behighly salmonella-contaminated chicken eggs to be co-mingled into liquidegg product with the only caveat being they be pasteurized to 5 logsusing the Se strain of salmonella as the measure which is not the mostheat-resistant strain of salmonella as found within chicken eggs.Further to the above the USDA through its Inspector General's Officepublished a report in November 2012 within which it reconfirmed that oneegg in 20,000 chicken eggs is contaminated with salmonella when asrecently as in 2005 another division of the USDA identified as theUS-FSIS claimed victory over salmonella as found within chicken eggs byreporting that current studies confirmed that the frequency of illnessesfrom salmonella in chicken eggs had diminished from one egg in 20,000 toone egg in 277,000. Subsequent to the USDA Attorney General's Report of2012 which contained criticism of agencies within the USDA for whatessentially contained a lack of job performance the US-FSIS Divisionwithdrew their claim that new studies confirmed the reduction insalmonella-caused illnesses from chicken eggs to be the mentioned oneegg in 277,000. Separately current publications on the same subjectmatter carrying dates of 2015 reconfirm that salmonella-caused illnessesstemming from contaminated chicken eggs continue to be the largestsingle cause of foodborne illnesses within the United States.

All of the above confirms the need for the public good that a reliablysafe chicken egg be made available to a public whose taste for such hasgrown from 4 billion dozen consumed in year 2000 to a number pushing 10billion dozen consumed currently.

For certainty of clarity of the uniqueness of the new discoveriesreported the current levels for inactivation of pathogens requirepasteurization to levels as measured in logs which never before could beaccomplished without coagulation of the subject chicken eggs. The newart resolves the issue of total inactivation of both viral and bacterialcontamination within chicken eggs while preserving both its nutritionaland functional raw characteristics including aesthetics. The utilizationof a shower over that of a bath is the preferred medium forpasteurization under the new art to perform the described protocol forreasons that the control of a sanitized environment is more readilyavailable through the use of a shower over that of a bath and theflexibilities of temperature, precision of length of exposure totemperatures and employment of ingredients are more readily available toprovide consistency of safety and functional qualities to the endproduct. Through use of programmed temperature changes of the spraywater set initially at the highest water temperature to be employedwhether targeting all of the subject chicken egg contents or separateelements within the subject chicken eggs the subject water preferably isapplied in the form of a spray or a mist which in either case willcontain an approved food-grade antibacterial agent. The temperature ofthe water spray is raised and lowered at frequent and prescribedintervals which are determined by their impact upon the outer albumen.The accelerated rate of pasteurization provided by the preferred initialwater spray temperature is reestablished when the mentioned outeralbumen receives additional heat derived from the temperature of thewater in whatever form it is applied to the eggshells providing that itis within a temperature range of 128° F. or above and continues toincrease in its temperature until reaching the preferred pasteurizationtemperature of 132.5° F. as used for these purposes of illustration. Thewater contained within the spray will contain a food-grade antibacterialagent except at the end of the pasteurization protocol employed. At theend of the pasteurization protocol employed a final rinse of the subjecteggs will be provided utilizing solely the food-grade antibacterialagent selected. For purposes of consistency of the end product eachbatch of eggs being pasteurized will receive water temperaturescontrolled by preprogrammed protocols which enable consistency of endproduct in terms of success in log levels of inactivation achieved aswell as assurance gained through automation that the end product hasbeen both fully pasteurized but damage to the raw characteristics of thesubject eggs has been minimized. The mentioned water temperature changesresult from controlled fluctuations of the initial egg temperatureachieved for the commencement of pasteurization as followed by thelowering of the temperature as preferably enabled through the use of ashower or a mist containing a temperature which is no lower than 128° F.for all internal elements of the chicken egg excepting the outer albumenwhich is programmed to fall to a temperature between 123 to 127° F.

As described hereinbefore the duration of pasteurization at eachtemperature setting is determined by such factors as size of eggs,altitude of the facility, chicken diet, variables in chicken waterconsumption among other considerations as would reasonably be known tothose skilled in the art of chicken egg production and processing.

Notably, overshooting of temperatures to reduce the total time requiredfor pasteurization can be performed but should be performed with care toensure that the benefits of total inactivation have occurred withoutdamage to the raw characteristics of the subject eggs.

Separately but importantly the outer albumen is being providedprotection from heat damage through lowering its temperatureintermittently from the initial water spray temperature setting whichfor these descriptive purposes is programmed to be 132.5° F. The new andunique protocol provides for continuous pasteurization of all elementsof the chicken eggs excepting the outer albumen which in pertinent partsconsists of the inner albumen, vitelline membrane and the yolk. Theintermittent application of heat enables continuous pasteurization tooccur for all of the denser elements identified which allows for theouter albumen singularly to receive special treatment. That specialtreatment to the mentioned outer albumen is the key element within thepasteurization protocol under the new art described herein which throughnew discoveries of how to utilize the outer albumen characteristics toenable the achievement of higher log inactivation of pathogens neverbefore achieved without damage to the raw characteristics of the chickeneggs and more particularly the outer albumen.

For clarity, post equilibrium between the water spray temperaturesetting and the eggs' internal temperatures having been reached andtheir equating to the preferred pasteurization temperature of 132.5° F.used as an illustration for these purposes the subject eggs dwell atthat equilibrium temperature for a selected time which becomes part ofthe cumulative time of the pasteurization process selected which in theend provides for the generation of the needed log reduction of thetargeted pathogen. In the interest of clarity the subject eggs areexposed to pasteurization at any time any element pertaining to the eggbody within the shell achieves a temperature of 128° F. or higher. Thequantity of heat transfer as measured in time to achieve logs willdiffer for each element of the egg. Therefore as each egg in terms oftemperature and in terms of each ingredient within each egg travels from128° F. to the pasteurization temperature selected i.e. for theseillustrative purposes 132.5° F. through the use of employing a spray forits application log reductions will occur to each of the recitedelements of each egg at different rates and in differing quantities. Theart form herein integrates the rates of heat transfer of each elementfound within a chicken egg. What has been learned is that each elementhas different levels of tolerance to heat. Those differing levels oftolerance enable non-exact levels of heat to be applied to certainelements while using the least flexible element as the base from whichdeviations may stem. As a pertinent example the outer albumen has theleast flexibility in heat tolerance as compared to other elements i.e.the inner albumen, the vitelline membrane and the yolk. Those referencedingredients qualify the outer albumen to be used as the vehicle ofchoice as such relates to overshooting the heat application and theresulting log achievements for itself and the vitelline membrane as wellas the yolk since each of those can accept additional heat as measuredin logs more readily than does the outer albumen. Notably, that novelinformation provides the flexibility required for the outer albumen tobe the baseline for the targeted log selected to achieve inactivation ofthe targeted pathogen. For the benefits derived through furtherexplanation a given virus may require a 10-log inactivation. That isaccomplished by the application and denial of heat giving cause to theouter albumen to only achieve pasteurization when at 128° F. or above asmeasured by logs. The denser inner albumen is slower to react to heatchange and slower to be damaged by heat than the mentioned outeralbumen. Therefore the new protocol provides for the outer albumen onlyto go below 128° F. at predetermined intervals and for predeterminedtimeframes which are below the minimum temperature that pasteurizationoccurs with reliable measurability. The inner albumen is allowed tofluctuate down to but not below the mentioned 128° F. because itsdensity is greater. That greater density gives cause to the inneralbumen taking longer for it to achieve the targeted log level than doesthe outer albumen. Hence the characteristics of the inner albumen givecause for it to continue to be within the temperature range for activepasteurization to occur. However, the inner albumen benefits fromachieving pasteurization without coagulation at higher temperaturelevels for programmed durations than previously achieved through the useof the intermittent or cyclical application of heat and heat denialdescribed and dictated by the differentiations of transfer rates asmeasured in time between each of the elements contained within the egg.Although the heat transfer rates of the elements composing an egg differin the end each of the mentioned elements of the egg when exposed to thenew art protocol will achieve the targeted log reduction of the selectedlog destruction targeted. Enough heat tolerance exists within eachelement of the subject egg to allow for overshooting the selected logreduction to accommodate the needs of the denser elements to reach alevel of inactivation which is complete as applied to the targetedpathogen selected. Such is made available through a combination ofadjustments to the cycle length representing the time taken to reach theequilibrium temperature for pasteurization, its holding time at thattemperature together with the time of denial of heat including inducedchilling which creates a full cycle. For clarity the shortening of thetime of the described cycle and the lowering of the preferredpasteurization temperature in a manner related to needs identified bythe characteristics of the batch of eggs being pasteurized will provideefficiencies to the length of times taken for completing a cycle ofpasteurization including the avoidance of heat damage to any element ofthe subject eggs. By extending the cycles to reflect a portion of theimpact gained by lowering the pasteurization temperature log levels canbe increased to provide for either or both higher levels ofpasteurization as measured in logs as well as enabling a lower risk ofcoagulation of the albumens as would be caused from a greater intensityof heat.

In principle the vitelline membrane and the yolk also in graduated formhave more tolerance to the rate of heat gain and heat loss whichmanifest themselves through a slower rate of change as caused by theinherent greater densities of those substances along with their moreremote locations from the heat source as provided through theapplication of water and not directly at the yolk which is a discussedalternate option for a different form of heat transfer. Notably, thepreferred protocol includes a water spray employing temperature changesas well as continuous purification together with an additive containinga food-grade antibacterial agent. All of the described ingredients arelocated and performed within the uninterrupted and protected environmentof the new and unique pasteurization medium. In the end depending uponthe very batch of eggs being processed in principle a formula is createdwhich employs the results from preliminary test analyses of therelationships between the targeted log levels and the eggcharacteristics which include the outer albumen as the baseline. Forbetter understanding in prior protocols it was learned that a size largechicken egg to achieve a 5-log pasteurization level on average took 2minutes less than did a size extra large. In principle that nature oftest runs can be performed to provide guidance to create a formularizedprogram which provides for the frequency and quantity of heat transferin terms of loss or gain to achieve log levels targeted to inactivatespecific pathogens as derived from the basics described within thecyclical program of heat application and its denial as claimed.

It is worth noting for better understanding that the above-describedfoundation facts concerning egg ingredients contain a natural orderwithin their location within the shell. That natural order ofingredients includes differing densities which correspond to differingrates of heat transfer according to the density of the subject substanceand transfers heat gain or heat loss at differing rates. As an examplethe yolk is impacted by heat and transfers heat at a slower rate thandoes the outer albumen. The new art applies that knowledge in a mannerwhich protects the outer albumen from heat damage while at the same timeallowing for the next most heat-sensitive inner albumen to receive heat.The inner albumen by virtue of its location and greater body densitywithin its substance than the outer albumen is provided protection fromdamage caused by rates and quantities of temperature changes whoseresulting damages are lesser than those of the outer albumen. Whilethose applications are occurring a cyclical effect is created whichincludes the application of heat and its denial to all elements withinthe subject egg unless the heat applied targets the yolk initially. Anelement of that cycle results from the vitelline membrane and the yolkcontinuing to receive heat which may exceed the targeted log level butwhen such occurs it is modest enough in its excess to not cause heatdamage to those denser but graduated elements.

In conclusion and as one illustration to the above the yolk compositionallows for modest overshooting of the targeted log while at the sametime the inner albumen does not have a composition which provides forthe same degree of flexibility before damage. In such an example theinner albumen may receive 12 logs while at the same time the yolk mayreceive 12.3 logs under the same protocol employed. What has beenlearned is that in practice the highest degree of inflexibility to heatdamage is found within the elements of the egg which contain the leastdense substances in their compositions i.e. the outer albumen and theinner albumen. Therefore the outer albumen needs periodic sanctuary fromthe heat as is provided from intermittent cooling through the protocolemployed which provides for lapses in heat from the preprogrammed waterspray temperature settings which allow for the outer albumen to quicklybecome protected from heat damage by cooling to levels below 128° F. andreturning intermittently as the heat through the program employed whichis referred to as being cyclical is increased. The inner albumen needsthe same nature of treatment but does not need the added protectionprovided from temperatures below 128° F. because its rate of heattransfer is slower than that of the outer albumen. It has beendiscovered that both the vitelline membrane and the yolk which containthe densest substances can use those denser substances to an advantageenabling higher log levels of inactivation of targeted pathogens becauseof their denser substance and less vulnerability to modest overshootingas compared to their less dense counterparts as found within the twomentioned albumens. Those described egg ingredient characteristics oncerecognized opened the door to discoveries which were incorporated into aformula that enable materially higher levels of pasteurization ofchicken eggs than all prior art could accomplish which in the endenabled the required levels of inactivations of all strains of bacteriaand further for the first time enabled log levels of inactivation ofviruses never before accomplished without damaging the rawcharacteristics of the subject eggs.

As previously discussed when heat is applied directly to the denser yolkthrough use of such sources which include microwave, ultraviolet, heatlamps, concentrated solar energy as well as radio waves adjustments tothe heat levels provided by the intermittent use of heated waterpreferably in the form of a spray or a mist will be employed to provideprotection of the vitelline membrane and the two forms of albumendiscussed in order to avoid either inadequate pasteurization or damageto those substances through excess heat applied. The alternateidentified vehicles for heat transfer directly to the egg yolks althoughdesirable to increase the speed at which pasteurization occurs carrieswith it risks that pasteurization to a targeted level directed to theyolk may succeed but may carry with it uncertainties that comparablepasteurization as measured in logs may occur without damage to the moresensitive and differing densities of the three albumen groups containedwithin the same egg in three different locations i.e. outer albumen,inner albumen and vitelline membrane. Since the new art effectivelydoubles the pasteurization protocol as measured through logs in order tosatisfy requirements that all pathogens which may be present within thesubject eggs have been inactivated the preferred art which is moremanageable for both measure and control are best achieved through theuse of water as applied by employing abrupt changes in temperature forvarying preprogrammed durations together with a food-grade approvedantibacterial agent either co-mingled within the spray water or appliedseparately which eliminate the uncertainties caused from utilizing twodifferent protocols to provide the combination of one result to thewhole egg i.e. pasteurizing the yolk to the targeted log level throughone means and pasteurizing the differing densities as found within thealbumen through separate means. Intermittent application of inducedchilling to the outer albumen is preferred over ambient cooling.

In recognition of jurisdictions which do not allow for the use of waterto be applied to eggshells an alternate and equally unique protocol canbe employed which consists of a combination of heat and ultraviolet asone area of several areas of options available which do not employ aliquid fluid as the vehicle for in-shell chicken egg pasteurizationwhile achieving log levels of inactivation of targeted pathogens whichas discussed herein throughout enables total inactivation of thetargeted pathogens to occur without consequential damage to the rawcharacteristics of the subject eggs. Once the protocol described hasbeen applied the then sanitized foreign and potentially contaminatedmatters attached to the eggshells and upon the pores can be wiped cleanwhich enables the benefits from the pasteurization provided to beretained while at the same time the appearance of the subject eggsgenerally will be free from unsightly signs of contamination. Post thecompletion of the protocol described the then pasteurized in-shellchicken eggs receive protection against recontamination through theapplication of a food-grade sealant whose base can be wax or a plasticpreferably through a form of application which provides protection fromexternal contamination post departure from the pasteurization mediumthrough to point of consumption.

Separately but notably the benefit from induced chilling when limited tothe outer albumen as intermittently applied throughout thepasteurization process selected for specific egg types and for specificpathogens targeted uniquely reduces the outer albumen's exposure to heatwhich makes available benefits that include the ability to providelevels of pasteurization never before available without damage to theraw characteristics of the chicken eggs. Those additional benefits notonly open the door for the needed higher log levels to provide forconsumer safety but also shorten the overall time for pasteurization toachieve the selected targeted log level from which the efficiency gainedfrom induced chilling also reduces the end product cost. Notably, theprotection to the outer albumen as provided by induced chilling enableslog levels of inactivation of targeted pathogens to occur which is anessential achievement to provide for assured public safety and is uniqueto this described art of new inventiveness. The employment ofintermittent induced chilling only will occur within the securedenvironment of the pasteurization medium whose designed security againstinvasion of pathogens provides protection against recontamination whichotherwise would be enabled to occur because the mentioned chilling givescause to the internal egg contracting which brings in unwanted pathogensthat are blocked or inactivated through the described cleansing featurescontained and provided on a continuing basis as found within the uniqueand secured environment within the pasteurization medium. In support ofthe above during contraction which occurs post-application of heat forpasteurization when within an impure environment as provided under allprior art impurities gain entrance into a chicken egg through its shellpores which is aided by the suction created from the contraction of theinternal elements of the subject eggs post-pasteurization.

Summary: For clarity and better understanding the pasteurization mediumreceives eggs which optionally may be pre-rinsed and sanitized beforecommencement of pasteurization. That optional protocol includes theemployment of a rinsing process of the in-shell chicken eggs to beperformed outside of the pasteurization medium in order to materiallyreduce entry of contaminants located on the eggshells from gaining entryinto the eggs through their exposed pores. That described externalapplication of heated water containing a food-grade antibacterial agentis useful to reduce risks of unwanted entry of contaminants located onthe shells of the eggs to be subsequently subjected to pasteurization.The blockage from entry of externally located contaminants includingthose which may be located on the eggshells is accomplished by applyingheated water at temperatures below 128° F. but higher than the internaltemperatures of the eggs subjected to the shell rinsing. That protocolenables the expansion of the internal eggs which blocks entry ofexternally located contaminants passing into the subject eggs throughexposed shell pores. The subject eggs after the described optionalexternal treatment are transferred into the isolated and securedenvironment of a new and unique pasteurization medium within which theyinitially receive a separate heated water spray containing a food-gradeantibacterial agent as part of the pasteurization protocol employed.

Under all variables of the pasteurization protocols available to beemployed each includes a protocol that provides for heating the subjecteggs during pasteurization to an extent that gives cause for the airsacks located at the blunt ends of the chicken eggs to reduce in sizedue to the expansion of the internal contents of the eggs as caused bythe mentioned application of heat. During pasteurization the heatemployed causes the internal bodies of the eggs to expand into thevoided space previously occupied by the air sacks. Under the newprotocol the environment created within the unique security provided bythe pasteurization medium allows for the protected use of sanitizedwater including food-grade chemical additives utilized for prescribedlimited durations, the intermittent applications of heat as well as theintermittent applications of induced chilling, utilization of sanitizedair provided by but not limited to combinations of ultraviolet light,filtration and reverse osmosis which in combination or separately ifemployed with continuity enables total inactivation without risk ofpathogenic survivors or recontamination of the subject eggs. Notably,that protocol not only provides for total inactivation of targetedpathogens but also provides for a fundamentally raw egg in both itscharacteristics and nutritional benefits.

For emphasis and further clarity the subject eggs post their optionaltreatment performed externally to their entry into the securedenvironment of the pasteurization medium are subjected to an increase oftemperature to achieve the preferred initial internal targetedpasteurization temperature of 132.5° F. which is used only as anillustration of the targeted pasteurization temperature to be employedfor these descriptive purposes. Once the subject eggs begin receivingheat post entry into the pasteurization medium the internal contents ofthe eggs begin their expansion. That expansion blocks entry of any straypathogens which at the end of the protocol employed within the securityprovided by the medium will inactivate stray pathogens along with allpathogens present within the medium as well as those within the subjecteggs. If stray pathogens remain alive and have not been forced to escapethrough the eggshell pores resulting from the expansion caused by heatof the internal egg contents at termination of pasteurization and whilethe subject eggs are ambiently cooling which provides for the internalegg to contract a final application of a food-grade antibacterial agentis applied to each of the exposed eggshells and through the combinationof internal contraction and exposed eggshell pores the mentioned agentis drawn inwards.

That final application of the described agent ensures the inactivationof any stray pathogens. The described final step of applying anantibacterial agent to the subject eggshells to ensure the inactivationof stray pathogens is followed by the application of a sealant whichenables the mentioned agent whose life may run a few days to continueits purpose in the inactivation of the mentioned stray pathogens ifpresent. Post the described protocol having been performed furthercontamination is blocked through the protected environment provided bythe medium within which post pasteurization and pre-exit the eggs aresealed through the use of the application of the mentioned food-gradesealants. Under the new art described and claimed herein new and uniquebenefits are made available through the redundancy of using a cyclicalapplication of heat and chilling to perform pasteurization of in-shellchicken eggs in a manner which provides certainty that a totalinactivation of targeted pathogens has occurred without consequentialdamage to the raw characteristics and nutritional benefits of a rawchicken egg. No prior pasteurization protocol of record can claimreliable inactivation of either or both excessive salmonella countsfrequently present within a contaminated in-shell chicken egg and viralcounts when summarily present within in-shell chicken eggs.

The protocols for the employment of new inventiveness enabling thestatistically complete inactivation of more aggressive andheat-resistant viral pathogens over those of bacteria create the needsatisfied by the unique features of the new art which provides for aselection of options from which the processor may select. The followingdescribes a selection which is not the preferred selection but will beuseful under certain circumstances peculiar to needs.

In recognition of jurisdictions which do not allow for the use of waterto be applied to eggshells an alternate and equally effective newprotocol has been discovered which succeeds in providing totalinactivation of targeted pathogens without use of water. Under thementioned discovery water employed for pasteurization is substituted bypurified air that is applied according to the art described herein whichuniquely employs intermittent applications of heat interrupted byprogrammed chilling of the subject eggs on a programmed basis which inthe end provides for levels of pasteurization as measured in logarithms(logs) which achieve both total inactivation of targeted pathogens whileretaining the raw characteristics and nutritional benefits of a rawin-shell chicken egg. The mentioned interruptions allow forpasteurization of the subject in-shell eggs to occur at higher levelsthan all prior commercial art has provided without damage to the rawcharacteristics of the subject eggs and particularly the most sensitiveelement to heat as taught to be the outer albumen. The heat transferwhether through air or water is performed through the use of nozzleswhich enable differing densities of heated or chilled water to besprayed on a pre-programmed basis directly unto the eggshells. Thetemperature interruptions created by the temperature changes caused byalternating heated water with chilled water as now adapted to includeair avoids heat damage to the highly sensitive outer albumen. Thatprotocol as more fully described herein before employs water as its baseingredient which under this section of the new art is substituted by airwhich when employed contains times of exposure to specific temperaturesettings that can be modified by parties reasonably skilled in the artto accommodate the modest differentials in heat transfer found to occurbetween the use of water and the use of air whether to accommodate aheat gain or a reduction of temperature resulting from the change oftemperatures within the protocol employed. In the end whether throughthe use of a water base or an air base the described art achieves loglevels of inactivation of the targeted pathogens which are total and areunique to the art described and claimed herein. For clarity, the new artin the form now outlined and claimed herein includes the ability tosubstitute water employed for in-shell chicken egg pasteurization withpurified air. The employment of purified air utilizing the applicableelements of the ingredients of the new protocol for pasteurizationemploying water as is also claimed herein can be performedinterchangeably within its key elements. Once the protocol described hasbeen applied the then-sanitized foreign and potentially contaminatedmatters attached to the eggshells and upon its pores can be wiped orblown clean. The new art enables the totality of food safety benefitsderived from the pasteurization provided to be retained while at thesame time the appearance of the subject eggs generally will be free fromunsightly signs of potential contaminants. Through the discoverydescribed herein regarding new and unique protocol contained within thenew art regarding the application and denial of heat as delivered by airas qualified to be a substitute for water such enables delivery of anend product of a chicken egg that is pasteurized to levels never beforeaccomplished which provides for the total inactivation of targetedpathogens.

Under the new art prior to exit from the secured environment of thepasteurization medium the application of a shell sealant is provided toprotect against recontamination from time of exit from the mediumthrough to consumption. Notably, current reports indicate that unwashedand un-refrigerated chicken eggs carry with them lower frequency ofsalmonella contamination. Such observations also include thedistribution of in-shell chicken eggs from farm to table to be performedat ambient temperatures although shorter shelf life is acknowledged. Oneof the underlying considerations includes the acknowledgement that thosesame jurisdictions frequently are supplied by smaller producers than arecommonly found in the United States. The protocol reported and claimedherein ends with the application of a food-grade shell sealant to beapplied prior to the already pasteurized eggs exiting from the protectedenvironment of the pasteurization medium. The food-grade sealant can beof a wax base or a food-grade plastic base either of which provideprotection against recontamination from processing through topreparation for consumption. That protocol provides for an option toallow the contaminants external to the eggshells to be subjected tototal inactivation of pathogens present as provided under the new art.Hence, the application of a protected sealant which has many benefits topublic safety can be applied to the subject eggshells post removal ofdebris carried with the subject eggs as may be attached to their shellswhich would be a singular step involving blown air to discharge cleansedbut unwanted substances as supplemented by automated brushing or wipingas the situation may dictate. Since the subject eggs would benefit froma food-grade sealant post pasteurization air blowing debris alreadycleansed as followed by the food-grade sealant may become a preferredoption.

The above-described new inventiveness provides for public consumption ofchicken eggs whether in-shell or converted into liquid egg productswhich allows for human consumption in all recipes without need ofhard-cooking to avoid risk of illnesses. Such is the result of the newart described herein providing total inactivation of pathogens currentlyfound or anticipated to become found within chicken eggs. Notably theinactivation of pathogens includes all strains of salmonella at alllevels experienced to exist within in-shell eggs as well as the moreheat resistant strains of viruses which require still greater levels ofinactivation than does salmonella bacteria.

For certainty of clarity in the first instance viruses are targeted tobe inactivated because the inactivation of viruses enables the automaticinclusion and destruction of undesired bacteria resulting from theirhaving a lower tolerance to heat than do viruses. In the second instanceviruses in their current form are forecasted to be converting into newstrains which already show signs of enabling human to human transferwhich in the end already has been forecasted to give cause to apandemic.

Although the forecast of a pandemic from viruses as found withinchickens and their eggs is worldwide in its sources and confirmationexists that the US through its Health and Human Service Agency havingfunded $150.0 million to perform research on a vaccine no protectionagainst the pandemic risk through pasteurization of chicken eggs hasbeen performed or even mentioned as being helpful particularly were suchto be expandable above current levels of 5 logs as applied to Se inorder to successfully inactivate all strains of salmonella at all levelsof contamination commonly existing but also all strains of viruses.

In summary the preferred option substitutes the described waterbathlocated within the protected environment of the medium with a drenchingshower, drenching mist or as otherwise preferred may include purifiedair at controlled temperatures and be applied in the same manner aswould be available through water in the form of a mist. Each of thechoices referenced includes an additive of an antibacterial agent whichprovides for each of the eggs to receive exposure that equates to thesame level of inactivation of pathogens targeted as would have beentargeted within the other options which include the less preferredwaterbath and the otherwise preferred use of a spray of water whichmight include its application in spray and mist forms. Both protocolswhether a shower or a bath in the end would use antibacterial agents offood-grade quality within the water of the medium selected but alsowould employ intermittent applications of heat and its denial to performtargeted levels of pasteurization more fully discussed within thissection as well as within the ‘Detailed Description of the Invention’section. The intermittent application of heat is of significantimportance to the discoveries cited herein which enable the totalinactivation of targeted pathogens while preserving the fresh and rawcharacteristics of chicken eggs. Because the previously-describedpreference over a waterbath is the use of a water spray or mist thatpreference is further enhanced by the benefits derived from both theease and the speed of converting a heated spray into a chilling spray toprotect the heat-sensitive outer albumen from heat damage i.e.coagulation. The described efficiency over the control of watertemperatures provides the further benefit of reducing the public cost ofthe end product through the cost savings gained from a shorterpasteurization cycle. Further to the above a spray is more certain toprovide continuously clean water blended with an antibacterial agentthan is a water bath.

Of equal merit to the preferred use of a spray or a mist to transferheat, the results of its denial or the applications of induced chillingto the subject eggs through even applications to the exposed eggshellshas been found to be equally effective through the use of a protocolemploying air versus water. That application of controlled airtemperatures applied through the air to the subject eggshells in amanner which is direct, even and at a consistent velocity includes theuse of food-grade non-liquid anti pathogen additives selected eithersingularly or in combination from ultraviolet, heat, microwave as wellas other cleansers discussed hereinbefore whether applied singularly orin combination as may be required to enable the total inactivation ofthe pathogens targeted.

Excepting the protocol for pasteurization that does not employ water inany form as part of its overall protocol which as discussed above can befound within cleansed air employed at specific temperatures andvelocities when applied as the preferred alternative to water employedin the form of a mist or a spray of treated water applied at deferringdensities post substantial pasteurization having been completed asmeasured in logs the eggs are moved from their above-referencedoptionally employed shower or immersion located at the entrance to themedium to a separate area within the medium at which point they receivea continuous spray consisting of coarse water optionally converted intoa mist of purified water containing a food-grade antibacterial agentwhich is applied at intermittent and predetermined temperatures. Thatoptional application provides for the optional partial cleansing of theeggshells prior to transfer into a pasteurization medium which reducesthe burden of the process employed within the medium. Notably, theoptional external rinse is at a temperature which is above the internaltemperature of the subject eggs but below the temperature of the mediumupon entry. Such temperatures provide for more effective externalrinsing which denies further invasion into the subject eggs of unwantedpathogens as carried by both air and foreign matters attached to thesubject eggshells.

With regard to the above-described protocol were the specific targetingof the egg yolk to be employed using electronic means as one of thevariables to how temperature transfer options hereinbefore describedwould be applied the shower in any of its optional forms i.e. a coarsespray, a fine spray, mist or otherwise would be adjusted to accommodatespecific needs concerning the subject eggs being processed which mayinclude such considerations impacted by changes to the time andtemperature formulas to provide for the direct application of heat tothe yolks of the subject eggs through the water spray temperaturesettings selected.

An alternate and preferred choice to the described treated water sprayor the treated water spray mist is contained within a direct applicationof a food-grade antibacterial agent applied directly to the eggshellspost-completion of pasteurization and pre-application of the food-gradesealant selected. That application is applied directly to the eggshellswhose pores are exposed. As the ambient cooling within the medium occursthe undiluted agent will be drawn inward into the bodies of the eggsthrough the shell pores which will provide protection against straycontaminants that still may exist within the secured environment of thepasteurization medium. During the described process the internaltemperature of the subject eggs continue to gradually diminish and theegg contents continue to contract internally which in both circumstancesare characteristic of eggs while cooling. The source of the residualheat available from final ambient cooling is located within the yolkwhose density and location gives cause for it to be the last elementwithin the eggs to reach equilibrium with the temperature of the mediumduring ambient cooling. The internal contraction of the eggs whilecooling post pasteurization draws inward the applied antibacterial agentto the eggshells which ensures continuing inactivation of straypathogens. While contraction of the eggs is occurring within the securedmedium post pasteurization and the temperature of the internal eggs isnearing ambient condition with the external environment to the medium apreferred sealant is applied to the eggshells consisting of a food-gradewax or plastic sealant in a preferred manner of application employing aspray which when applied is drawn into the eggs through their exposedshell pores which seals the eggshells from external penetration bypathogens. The eggs have two membranes located between the eggshells andthe body of the eggs which contain their contents. Those membranestogether with the shell sealant collectively provide additional securityfrom recontamination stemming from external sources utilizing exposedshell pores as their source of entry. Upon completion of thepasteurization protocol the eggs exit the protected environment providedby the medium.

The above-described elements employing treated water in the form of aspray or a mist as preferred over a water bath is applied directly tothe chicken eggshells. Under the new art claimed herein that protocol ischanged from the use of purified water to the use of purified air. Theinclusion of the option of purified air is employed together with thecombination of features contained within the new art which primarilyconsists of but is not limited to a secured medium within whichpasteurization is performed. Such enables for the first time totalinactivation of targeted pathogens including all strains of salmonellaand viruses containing all levels of contamination to be eliminated frombeing the source of risks provided from the transfer of pathogensexternal to a newly laid chicken egg to be transferred by water into thebody of the egg. Nonetheless, that gain in safety continues to carryrisks of the natural sealant becoming in effective over time andallowing for the passage of contaminants to flow into the subject eggs.Those issues have benefited albeit minimally from recommendations forrelatively prompt consumption which otherwise opens the door to givingcause to illnesses. In those jurisdictions relying upon the naturalfeatures of a chicken egg and the prompt consumption of those eggs atminimum the public may find materially improved safety from what wouldbe a natural inclination to allow eggs to become older than the timewhen they actually should be consumed in the first instance. In thesecond instance the obvious solution to provide the public with extendedshelf life without health risks from a source not dependant uponrefrigeration would be through a water free protocol of pasteurizationachieving levels of inactivation of targeted pathogens which iscomplete. Of equal importance it is common knowledge to the scientificcommunity that viral contamination requires inactivation to avoidillness and likely death to members of risk groups. Employing a naturaltemperature and a natural condition of in-shell chicken eggs from lay totable to avoid the spread of contaminants through use of water tocleanse eggshells and to rely upon ambient temperatures through toconsumption clearly has become an avoidable risk. The increased risksinclude but are not limited to a growing source stemming from largerproduction facilities giving cause to shipments at greater distanceswhich in combination increases the average time from lay to consumption.It is common knowledge that one-salmonella cell at ambient temperaturewill multiply into lethal quantities within thirty days of lay. Equallyit is common knowledge that a contaminated chicken egg at time of layfrequently contains more than one contaminated cell. The advent of risksalready present and confirmed to be evolving as provided from viralcontamination makes obvious the need for safety resulting from anun-invasive form of pasteurization of in-shell chicken eggs whichprovides a threatened public with assurance that total inactivation oftargeted pathogens whether present or evolving as found within bacterialand viral contaminants now can be compromised fully without loss of anyof the enjoyable features found within a clean and fresh chicken egg.Through the protocol provided under the new art described herein such ismade available without compromising the gained benefits through risks ofspreading contaminants resulting from the use of water as the cleansingvehicle.

Under the new art the combination of a secured medium to process eggsprovides a proven and effective barrier from airborne contaminants tolocate upon the matters attached to chicken eggshells post lay as ismagnified by the egg contracting internally post lay which creates amild but significant air current attracting airborne contaminants tojoin with the contaminants present within the foreign and frequentlycontaminated substances found upon eggshells at time of lay.

Under the new art an option for continuation of the practice of notwashing eggshells is provided without the penalty or risk of allowingsubsequent contamination to occur internally to the chicken egg once thenatural sealant has either become ineffective from the passage of timeor physically compromised from cracks and dents to the eggshells.

Through pasteurization performed without the use of a liquid fluid theconcerns of increasing internal contamination of chicken eggs areeliminated. The raw characteristics substantially are preserved alongwith nutritional benefits. Even under ambient conditions shelf life isextended.

Notably and significantly a further benefit to all of the above now isgained and made available through in-shell chicken egg pasteurizationemploying new art which achieves inactivation of pathogens to a newlevel which for the first time provides for the total inactivation oftargeted pathogens whether through inactivation of all strains ofsalmonella or through inactivation of all strains of newfound threatsfrom viral contamination which require still greater levels ofinactivation than do any and all strains of salmonella as found withinchicken eggs.

In conclusion, both notably and significantly, the new and materiallyhigher levels of log reductions of pathogens which may be present uponor within chicken eggs are now made available for total inactivationthrough new and unique art which utilizes a collection and uses ofprotocols in a novel manner that provide for what effectively is thetotal inactivation of pathogenic contamination of chicken eggs while atthe same time providing for the denial of recontamination or risks ofincomplete levels of pasteurization while maintaining the nutritional,aesthetic and functional characteristics of a raw chicken egg. Thatflexibility which is unique to the new art described enables productionof safe eggs to include the additional benefit of having recaptured thenatural taste of the egg while at the same time delivering astatistically safe egg for use in all recipes and to provide the benefitof safety to most particularly the 150.0 million persons within theUnited States identified to be at high risk of illness caused by unsafefoods. In the absence of a forecasted viral threat the same new art ofpasteurization can be adapted through adjustments of the length of timeof heat application to satisfy the destruction of salmonella onlythrough total inactivation requiring a minimum of 10 logs which currentart fails to provide without negatively impacting upon either theaesthetics or functionality of the targeted eggs. Said mentioned 10 logsas applied only to the destruction of salmonella allows for a safetymargin to protect against more heat-resistant strains or deviationswithin strains which likely will continue to occur. The describedseparate pasteurization protocols i.e. for viral or bacterialcontamination will be useful were the pandemic as caused by viralcontamination not to continue to be a threat to public health and werethe targeted contaminant to revert back to solely a bacterial sourcesuch as salmonella. Were the threats of viral contamination of chickeneggs to pass the bacterial contamination will continue to requirematerially greater inactivation than the current U.S. Government 5-logrequirement for the strain of Se provides. The need for bacterialprotection from contaminated chicken eggs will continue to require a10-log protocol to accommodate current risks as derived from levels ofcontamination of recent record continuing along with a reasonable marginfor added safety. That continuation of need to counteract salmonella inchicken eggs is the result of the built-in unhealthy environments forcaged chickens which are common to the industry which traditionally hasbeen motivated by low-cost, high volume enterprises resulting inuncontrollable unhealthy environments for the hens which translate intoinordinate quantities of contaminated eggs primarily caused by unhealthyhens together with a contaminated environment. That chronic problem iscompounded by the discussed risks of increased contamination as enabledby distribution from farm-to-table mistakenly relying solely upon nearlyimmediate and deep chilling promptly post-lay as the only source ofprotection from known-to-be already contaminated eggs.

The inadequacies of a 5-log inactivation are common knowledge to thescientific community. Also it is common knowledge that the mentionedinadequacy enables the regeneration through multiplication of thesalmonella cells when exposed to temperatures above those provided bycontinuous and deep refrigeration which results in the salmonellareaching lethal counts in a matter of days whether through absence ofdeep refrigeration, intermittent refrigeration or co-mingling ofhighly-contaminated eggs with those of less contamination as allowedunder the Final Rule of 2009 which has been common practice for decades.

Further to the above attention is drawn to the already recited practiceswhich exasperate the already significant risks to public health causedby contaminated chicken eggs together with the loss of public dollarspotentially measured in trillions resulting from those practices. Thosepractices include but are not limited to illnesses and deaths causedfrom repackaging of eggs of stale dates into new packages containing new‘Best By’ dates in the first instance. In the second instance theacknowledged practice of including two plus Grade B eggs in 12-eggcartons labeled as either Grade A or Grade AA is both immoral and likelyillegal. Such is magnified by agencies of jurisdiction being party toproducing public health statistics which confirm that 45% of thepopulation consists of persons with compromised immune systems andmislabeled eggs not only is causing greater numbers of illnesses, anddeaths but also when calculated in dollars using any reasonable formulathe result is an avoidable public cost measured in trillions of dollars.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a typical section of flats containing chicken eggsprepared for pasteurization which in practice will be multiplied inquantity to accommodate production suitable to the location of thepasteurization processing facility.

DETAILED DESCRIPTION OF THE INVENTION

As has been discussed and noted above, there are several differentelements contained within the invention. Each element is important untoitself. However, when employed together their combined contents createfor the first time the ability to provide a total food safety benefitfor the chicken egg consuming public through two new primaryachievements. The first new primary achievement is a method that enablesthe total inactivation of salmonella, as well as viruses, which in thecase of viruses potentially pose a still greater threat to public healthfrom chicken eggs than does salmonella when chicken eggs are consumedless than hard-cooked. As noted above, the total inactivation oftargeted pathogens occurs under the new art contained herein throughprogrammed interruptions of heat and its denial, which also is referredto as being cyclical in its nature. That described protocol enables forthe first time the ability to inactivate all bacterial or viralcontaminants contained within or upon in-shell chicken eggs.

The second new primary area of inventiveness is referenced as being thepasteurization medium. The pasteurization medium is peculiar to the newart claimed herein. The new medium enables total inactivation ofsalmonella as well as viruses to be performed within the medium, whoseself-sufficient features provide for a fully secured environment, whichincludes perpetual cleansing of the chicken eggs during pasteurization.Under prior art no such secured medium existed. As a result of theabsence of a secured environment in the prior art, significant airbornerecontamination resulted from the difficulties of controlling the purityof the air within the environment within which pasteurization wasperformed, as well as the contaminated environment into which thesubject eggs flowed post pasteurization. Such allowed for subsequentairborne impurities giving cause to inordinate levels ofrecontamination. The achievement of providing security fromrecontamination is the result of the mentioned unique medium containingits own internal purification system, which avoids any risk of targetedpathogens surviving the protocol employed. That mentioned internalpurification system includes the perpetual use of any one of the US-FDAFood Use approved bactericides, which include but is not limited tochlorine, ozone, hydrogen peroxide and quaternary ammonium. Notably,chlorine will become inactivated when exposed to temperaturescustomarily employed for in-shell chicken egg pasteurization. At pointof exit, the eggs exposed post pasteurization performed under thereferenced art within the medium described, not only are pasteurized toa level of inactivation which is total, as applied to the two primaryrisk areas consisting of bacterial contamination and viralcontamination, but also the subject eggs are protected fromrecontamination by a protective sealant being provided to the eggshellsprior to the subject eggs exiting from the sanitized environmentprovided by the pasteurization medium. Notably, once the subject eggsare conveyed into the secured environment of the pasteurization medium,the protocol for pasteurization, together with the control of theimpurity of the environment are sealed and the protocol employed forpasteurization of the subject eggs is both preprogrammed, as is themaintenance of the purity of the environment within the medium. Uponsubstantial completion of the pasteurization protocol employed, andwhile the subject eggs are ambiently cooling and still contractinginternally, the egg shells are provided with the selected and approvedfood-grade antibacterial agent without dilution, to further ensure totalinactivation of the targeted pathogens has occurred. Post application ofthe mentioned agent, and prior to exit from the medium after thecompletion of pasteurization, together with the subject eggs havingreceived a protected sealant, is the security of the environment relaxedto provide for the exit of the pasteurized eggs containing theirprotective sealant, which except for occasional unavoidable damage to agiven egg, will provide the public with a pathogen free egg suitable forconsumption by the general public without restriction.

As has been discussed and noted above under the ‘Summary of theInvention’ the new influenza threat spanning the globe has a viral basesource which generally is identified as Avian Influenza that is commonlyreferred to as the bird flu. In the pasteurization processes describedand claimed in the above-noted patent ingredients pasteurization iscarried out in optional forms by way of intermittent applications ofheat as contained within purified water through application of a sprayor a mist as one option. A second option employing the same securedenvironment of the medium employing a similar protocol as that of thedescribed water is employed by the substitution of the water in all ofits forms with purified air. Each of the two preferred applicationsi.e., water and air as described, are preferred over the selection of awater bath for reasons more fully discussed under the prior sectionentitled ‘Summary of the Invention’. Under the protocol employed withinthe new art, whether purified water or purified air is employed, theselection is similarly programmed to fluctuate in its temperature,enabling the subject eggs being pasteurized to be protected from heatdamage, which if not protected, would give cause for the subject eggs toloose their raw characteristics. The new art as is more completelydescribed herein above by reference is included within this section.More particularly, reference is made to the portion of the new art whichboth protects the subject eggs from risks of heat damage, while at thesame time and for the first time enables the inactivation of targetedpathogens, which include all strains of salmonella and all strains ofviruses as found or may come to be found within chicken eggs. Thesedescribed features of the current invention are most important. Toachieve the inactivation results of the targeted pathogens referenced,the protocol employed includes the optional uses of treated water ortreated air applied to the chicken eggshells employing differenttemperatures for different durations on a preprogrammed basis, selectedto accommodate the specific pasteurization needs to satisfy theinactivation of the pathogens targeted within the variables containedwithin the subject eggs, and their specific needs, as applied to thetotal inactivation of pathogens potentially present through the benefitsof pasteurization, achieving the level of total inactivation of thetargeted pathogen, according to standards set and confirmed by science.To accomplish such, the choices of the fluid employed, whether purifiedwater or purified air at controlled and preprogrammed temperatures forpreprogrammed durations, as further tailored to accommodate the specificfeatures of the subject chicken eggs, are the primary considerations forthe selections for either heat transfer or chilling transfer to occur.The selection of treated water or the selection of treated air as thetransfer vehicle for either heat or induced chilling within theself-sufficient and secured environment of the pasteurization medium isaided and reinforced in either case by added ingredients describedpreviously herein above. That section includes options for sanitizationprovided through appropriate adaptations of alternate sources availablewhich both are identified and demonstrated through the potential use ofsteam as a feature of water, microwaves as an option, ultraviolet or itscounterparts as a constant within the medium added to the protocolemployed as either a substitute for or a supplement to treated and bothheated and chilled water or treated and both heated and chilled airutilized for the intermittent transfer of heat and its intermittentdenial together with the intermittent application of induced chillingand its intermittent denial to the subject eggs under a programmedprotocol attending to the specific characteristics of the subjectchicken eggs.

The new and significantly important inventiveness described and claimedherein concerning pasteurization of in-shell chicken eggs also providesfor a new and unique total inactivation of pathogens present whichenables the conversion of the subject pasteurized in-shell eggs intoliquid egg products, which currently give cause to significant healthrisks to the consuming public resulting from inadequate pasteurization.The inadequate pasteurization as applied to salmonella inactivationresults from the current protocols employed for pasteurization of liquidegg products, as well as the levels of salmonella counts known to bepresent within chicken eggs being converted into pasteurized liquid eggproducts, employ a 5-log level of inactivation of salmonella although byregulation counts requiring up to a 10-log level of inactivation areneeded. That protocol allows for the level of pasteurization used forchicken eggs being converted into liquid egg product to be well belowthe needs required to inactivate highly salmonella contaminated chickeneggs. That existing and significant problem is compounded by the now newand potential presence of viruses, which require still greater levels ofinactivation than do salmonella strains. Whether from contaminatedin-shell chicken eggs or from co-mingled and inadequately pasteurizedliquid egg products, the present public health risks as carried bycontaminated chicken eggs now can be eliminated through the employmentof the protocol described for improved and total inactivation ofpathogens contained within chicken eggs through the results ofpasteurization, which now provides for inactivation that is total whichincludes both salmonella bacteria as well as viral strains evolving,which prior art as practiced failed to address.

Separately but of distinct importance the new art through all of itselements enables not only the inactivation of pathogens already as foundwithin chicken eggs, which include bacterial strains and viral strains,but also those which may come to be found within derivative strains thatevidence confirms likely are to occur. Those new strains may include theneed for greater protection from pathogens more resistant to heat. Underprior art protocols employed for pasteurization, inactivation ofpathogens possessing newfound resistance to heat is unavailable. Theirinactivation now can be satisfied through the new art being discussed,which provides for the achievement of still higher levels ofinactivation, as enabled by the art contained within the newpasteurization protocol employed that has been more fully discussedhereinbefore. Under the new protocol enabling the total inactivation ofviral strains, the level of heat application to achieve saidinactivation of the viruses exceeds the heat application required toinactivate all strains of salmonella bacteria as may be found withinchicken eggs. The new art herein presented inactivates all salmonellastrains as may be found within chicken eggs stemming from sourcesoriginating from external contamination, as well as those originatingfrom within the chicken and its ovaries. The new discoveries discussedas found within the new art as described hereinabove not onlyinactivates viruses as now increasingly may be found within or uponchicken eggs but also inactivates all salmonella strains which too maybe commonly found within or upon chicken eggs. However, it now has beenlearned from new teachings that an increase in heat tolerance isoccurring within the various strains of both salmonella and viruses asfound or may come to be found within chicken eggs. Those evolutionarychanges give cause for needs to provide levels of pasteurizationcontaining the ability to inactivate pathogens that have acquired heatresistance resulting from their evolution to protect themselves, whichnow require pasteurization levels that are materially higher than a5-log level of inactivation as measured by Salmonella enteriditis (Se)and as approved to be safe by Government agencies. The constantevolution of pathogens gives cause for pasteurization levels employed tocontain adequate flexibility, which enables pasteurization technology toprovide total inactivation in order to keep pace with the on-goingincrease in heat resistance occurring within the targeted pathogens.Uniquely and importantly the new art described hereinbefore accommodatesthe previously mentioned needs to satisfy the inactivation of pathogenswhich have growing levels of contamination caused by the mentionedevolution of pathogens through use of the unique features containedwithin the new art described enabling the achievement of log levelsrequired for total inactivation through the use of the cyclicalapplication of heat and its denial which enables the achievement of thetargeted log without deterioration of the raw characteristics of thesubject eggs.

For further clarity, in practice the new inventiveness through itsprotocol provides for a level of viral destruction or inactivation of10-logs or greater as may be needed to accommodate the inactivation ofviral strains which require additional log reduction over that of themost prominent and heat-resilient bacterial strains currently causingcontamination of chicken eggs. Although Se is not the mostheat-resilient strain of salmonella commonly found within chicken eggs,it is used by Government agencies as the baseline for measuringsalmonella inactivation as measured in logs. The USDA ResearchLaboratory has reported that an inactivation ratio between the H5N1virus and Se as measured in logs applicable to Se equates to 5.0- to7.0-logs of the bacteria (Se) to 5.0-logs of the virus. Therefore,concurrent to achieving a 10-log destruction of the more heat-resistantstrains of viruses as now is enabled and not exclusively found withinthe H5N1 strain when compared to the lesser heat-resistant strains ofsalmonella bacteria, the new inventiveness inactivates all salmonellacontamination commonly found within chicken eggs including the moreheat-resistant strains of salmonella, which as just two examples arefound in S. Senftemberg 775 W and S. Heidelberg, for reason that scienceconfirms that the viral contaminants require greater levels of heatexposure for their inactivation than do all other strains of salmonellaas commonly found within chicken eggs as is known to those within thescientific community who have both reported upon the subject area andare credentialed within the subject field. Experts at the USDA ResearchLaboratory have reconfirmed that the inactivation differential betweenviral inactivation and bacterial inactivation as found within strainsthat may become peculiar to chicken eggs require Se inactivation to beup to 2-log levels greater than the virus log level targeted in order toinactivate the viral contaminant. Example: A 12-log inactivation of theSe bacteria more or less may equate to a 10-log level of inactivation ofthe H5N1 virus. Although research reports are on-going regarding stillnewer virus strains becoming the source or a participant source of aforecasted pandemic stemming from avian causes, an antibody does notexist in final form for reasons that a current antibody as of May 2014still was being tested and also reportedly the H5N1 virus was continuingto evolve as confirmed by various international sources including theWorld Health Organization (WHO). Notably, the scientific communitythrough its writings confirms that it is a near certainty that moreheat-resilient strains of either of the mentioned contaminants or theirderivatives will continue to evolve and give cause to increased threatsto public health within the forecastable near term. The continuedevolution of viruses which includes their gain in resistance to sourcesof inactivation confirms the need for science to be ahead of thepathogens in their inactivation which is made available by the new artdescribed herein.

Notably, the new art employs pasteurization and not sterilization. Inpertinent part, pasteurization preserves nutritional values within thefood source targeted, whereas sterilization loses the nutritional valuesof the food targeted.

In summary, the first of two areas of new and primary inventivenessunder the new pasteurization art described herein and claimed as newinventiveness includes the unique ingredients of the protocols employedresulting from new discoveries, which provide the ability to accomplishthe inactivation of both viral and bacterial contaminants as enabledthrough redundancy of the application of heat and the unique denial ofheat intermittently applied to the least dense but most rapid heattransfer element of the various elements contained within chicken eggs,which is found to be characteristic of the outer albumen. That describedintermittent application and denial of heat, as controlled and measuredby and from the outer albumen, represents the primary control point ofthe new and unique protocol employed, which enables the achievement oflevels of inactivation of targeted pathogens never accomplishedpreviously without loss of the raw characteristics of the chicken eggs.That described new knowledge has led to new discoveries disclosed andclaimed herein which now enable the inactivation of both viral andbacterial contaminants as found within chicken eggs or as forecasted tobecome sources of contamination to chicken eggs through viral mutationsof existing strains or from independently evolved new viral strains,which in each instance require materially greater heat exposure toachieve inactivation than does salmonella bacteria in all of its formsas may be found to be associated with chicken eggs.

Notably and materially, the present state of the art cannot deliverinactivation of any targeted virus or new threat from any sourcecurrently evolving as studied and reported by the scientific communityto a level of log destruction as measured by Se without damaging the rawcharacteristics of chicken eggs whether in-shell or within liquidproduct form or whether whole or separated into albumen only or yolkonly, while at the same time inactivating the new viral strains orspecies of contaminants known to exist and known to be continuing toevolve into a public threat caused by a virus which is capable ofsickening the public through either human-to-human transfer or throughan inordinate quantity of illnesses independently encountered by theegg-consuming public. Of equal notability, the Government itself forreasons which remain unclear, reduced the inactivation level of allstrains of salmonella as found within chicken eggs from 10-logs to5-logs which only compounds the current problem the public is facing forthe need for protection from both salmonella and viral sources as foundwithin both liquid egg products and in-shell eggs which Governmentscientists for decades have confirmed require a 10-log level ofinactivation for bacterial strains.

Separately, the details of the new art described herein include thereplacement of the prior art risk providing protocol of employing a5-log level of pasteurization as may be found within a contaminatedchicken egg without qualifications provided to the public in advancethat the subject eggs frequently may cause illness or even death.

Notably and of primary importance, the new discoveries in material partemploy the advantages provided from the significant differences foundwithin both the heat transfer and heat retention of the outer albumen,as compared to each and all of the other elements of the chicken eggs.For clarity of understanding, the outer albumen contains differentcharacteristics and a different density in its composition from those ofthe inner albumen, vitelline membrane and the yolk. Those differingcharacteristics most significantly include the lesser density of theouter albumen as compared to the densities contained within the inneralbumen and the vitelline membrane as well as the yolk. The differencesin the densities of the mentioned substances together with theirdiffering proximities to the heat source, whether those sources arebeing provided with heat or with an absence of heat or still furtherhave been subjected to induced chilling enable new teachings to occur,when understood and considered together provide for the first primaryelement of new inventiveness to occur. That new first element isdependant upon the unique use of the composition of the outer albumen incombination with its unique location in relation to the eggshell andproximity to the source of heat or chilling. The outer albumen'scomposition and location, in combination with its thinnest relativecomposition provides for the outer albumen to be the key measure ofcontrol of heat transfer over all other elements within the subjecteggs, as derived from the advantages provided from the outer albumen'shigher rates of heat transfer whether from heat gain, heat losspost-heating and induced chilling. That protocol provides for heatdamage to the outer albumen to be eliminated, while at the same time theexposures of all other elements of the subject eggs, including theirgraduated denser compositions as represented by the inner albumen,vitelline membrane and the yolk, benefit from prolonged and interruptedapplications of heat, its denial and the inclusion of intermittentinduced chilling to achieve the desired higher targeted log reductionselected without loss of the inherent raw characteristics of the subjectchicken eggs. The benefits from the discoveries derived from utilizingthe different densities of the egg components together with theirresulting differing rates of heat transfer enable higher log levels ofdestruction of targeted pathogens to occur without damage to the rawcharacteristics of the subject chicken eggs. In the end, this new andparticular area of discoveries addressing the differing elements of theeggs and their varying rates of heat absorption and heat discharge areutilized in a unique and positive manner, which enable greater loglevels of pathogenic inactivation of targeted pathogens than prior arthas achieved without negative impact upon the raw characteristics of thesubject chicken eggs. That achievement of inactivation of both virusesand bacteria is enabled through the described new inventiveness, whichnot only enables new threats from viral contamination to be compromisedfully but also concurrently provides for the total inactivation ofin-shell chicken eggs contaminated with any and all strains ofsalmonella as may be found within chicken eggs. On the other hand, theprior art never fully achieved this level through the use of aninactivation level of 5 logs, as applied to Se as was established by theUS-FDA and employed for both known to be highly salmonella-contaminatedchicken eggs regardless of whether such eggs would be provided to thepublic as in-shell chicken eggs or as liquid egg product. Certaindefenses to the inadequacies described from not only the reliance upon a5-Se log level of inactivation have been provided through utilizingprompt pasteurization together with prompt chilling. Neither of thementioned supplemental treatments of promptness of pasteurization or theemployment of deep chilling is reliable to provide food safety. In thefirst instance, the achievement of a deep chilling temperature for eggsstacked in a commercial environment requires several days to achieve.Were the eggs to be contaminated, the level of contamination increasesmaterially while the chilling is being applied. Secondly, recentGovernment statistics confirm that the level of chilling frequently isinadequate to eliminate the growth of contamination present. Stillfurther, chilling does not inactivate pathogens present. At best,chilling if totally successful, interrupts pathogenic multiplication.Still further, even post chilling interruptions in shipments and theirassociated chilling from farm to table are more common than uncommon.Such is the result of inadequate chilling to begin with, vehiclebreakdown en route, power outages and a host of other natural butfrequently occurring events. In support of inadequate chilling on itsface posing a risk to public health, reference is made to a reportauthored by the USDA Office of Inspector General dated 2012, withinwhich it recites the risks of reliance upon chilling to abortmultiplication of pathogens contained within chicken eggs that givecause to salmonella contamination at a frequency of 1 egg in 3,600 eggsas containing initial levels of salmonella contamination. The issue wasfurther addressed in a report from a publication entitled ‘NEROComments,’ as written by that association's experts within the field.The report covers a multitude of ethical and illegal violations, whichremain on-going and includes among other on-going public health risksthe practice of repackaging eggs of stale date already containing acombination of Grade B eggs co-mingled with Grade A or AA eggs intocartons containing a new ‘Best By’ date as now extended for anadditional time more or less equating to thirty (30) days. Privatecalculations indicate that three (3) salmonella cells exposed toreasonable ambient temperatures for a period of thirty (30) days postlay will achieve in excess of 100 million cells of Se. Separately, inorder to achieve targeted log reductions and to avoid the risk ofoff-tastes as carried within a chicken egg that has absorbed either thearoma of manure or fowl air from the environment within which it waslaid, additives to liquid egg products frequently are employed. Thoseadditives generally are unnoticed by an uninformed public, whichincludes risk groups representing 45% of the population i.e. 150.0million persons as having compromised immune systems. The additivesemployed in certain selections provide for a modest increase above 5logs to inactivate salmonella. However, the product remains to be unsafefor consumption once co-mingled with US-FDA-authorized highly salmonellacontaminated chicken eggs, which in the end require approximately twicethe 5-log level of inactivation of salmonella, as measured by the Sestrain to be safe for consumption unless hard cooked.

Importantly, the new art claimed herein initially targets apasteurization level for chicken eggs as measured in viral logs to be a10-log level of inactivation of the H5N1 virus as being representativeof the pertinent viral group. At the same time, through the intermittentapplication of heat and its intermittent denial which is unique to and afundamental part of the new art, the present inventiveness providesprotection against coagulation of the outer albumen that otherwise wouldgive cause to the loss of the raw aesthetic and functionalcharacteristics of the subject eggs. Consequentially, were it to occurthat a 10-log level of inactivation of viruses as found within chickeneggs is inadequate to inactivate all viruses present, the new artprovides for a programmed continuation of the cyclical application ofheat and its denial to be extended employing a preferred option ofinduced chilling. The present inventiveness enables the totalinactivation of the targeted pathogens without giving cause to loss ofnutritional benefits or functional benefits of the subject chicken eggsas compared to their raw counterparts.

The new chicken egg pasteurization art employs an initial 12-loginactivation of salmonella, which in its end result effectively equatesto a 10-log inactivation of viruses. Viruses currently are becomingpresent in variations that are more deadly to humans and moreheat-resistant to pasteurization than all strains of salmonella as foundwithin chicken eggs. Further to the above, under the new art, theinactivation of salmonella no longer is tied to Salmonella enteriditis(Se), which recent science reconfirms is not the most heat-sensitive ofsalmonella strains common to chicken eggs. However, by custom,Government agencies continue to reference Se as the targeted strain ofsalmonella, along with identifying the ovary of the chicken as being theprimary source of salmonella contamination in the form of theenteriditis strain (Se), which is inactivated through a 5-logpasteurization protocol as claimed by the US-FDA. At the least both the5-log protocol and the source of contamination as being primarily fromthe ovaries are suspect. Notably and significantly, the new art claimedherein resolves any risks of misinformation by providing the public withwhat undeniably is a statistically safe egg.

The materially higher levels for total inactivation of both of thementioned pathogen groups are enabled by a new and unique pasteurizationprotocol employed within an equally new and unique purified isolatedenvironment to be found within the medium employed. That protocolcontains new and unique features which can be employed to either or bothof the mentioned pathogen groups separately or concurrently. The presentinvention includes the application of heat through a purified watersource or optionally a source employing purified air, which in either ofthe options employs heat applied at a predetermined temperature settingof 132.5° F., for these illustration purposes only. That watertemperature will be identified and treated as the preferredpasteurization temperature, which is applied in its preferred formthrough a spray or a mist or in an equally effective form through use ofpurified air applied directly to the eggshells of the subject eggs atspecific temperatures, at specific intervals and for specific durations.These parameters are determined primarily but not solely by influencescaused from the environmental characteristics of the location of theprocessing facility and the source location of the subject eggs, eggcharacteristics generally and the individual local characteristics ofthe subject eggs.

From the information discussed herein above, a new art has beengenerated which is employed through a new and unique formula adaptableto the described conditions precedent, which through its flexibilityaccommodates pasteurization exposure times of the subject eggs. By doingso, this invention not only to provides a level of pasteurization, asmeasured in targeted logs, through adjustments to accommodate particularlocal characteristics influencing the subject eggs together withproviding a level of inactivation of the targeted pathogens intended asadjusted in all applications to accommodate not only the differencescontained within chicken eggs as to size and contents but also thequantity of inactivation as required for the total inactivation of eachpathogen targeted. Such is accomplished through the controlledemployment of heat and the denial of heat applied to the shells ofchicken eggs, optionally through the use of a spray or a mist of waterwhich also will contain an approved food-grade antibacterial agent. Theapplication of the water in its mentioned forms to the subject eggshellsemploys different temperatures for different durations which are derivedfrom formulas that accommodate the quantities of heat required toachieve the targeted inactivation of the targeted pathogens, as measuredin applicable logs (logarithms), without consequential damage from heatto any one element of the chicken egg. The art in practice utilizes theapplication of heat and its denial to be prompt through use ofconsistent temperatures for specific durations programmed to accommodatethe egg characteristics present, the log level targeted for inactivationand the adjustments to accommodate exposures necessitated from differingegg characteristics being subjected to the pasteurization protocol beingemployed. The programmed protocol is adjusted to reflect not only thetargeted log level to be achieved for inactivation of the targetedpathogens but also includes modifications of the time and temperatureemployed to reflect accommodations to the differing individual eggcharacteristics. Those mentioned considerations are further adjusted toreflect the inactivation of the targeted pathogens as such applies tothe duration of the application of heat and its denial as optionallydelivered through a fine spray or a mist of water at predeterminedtemperatures and for predetermined time intervals, which also cancontain a food-grade antibacterial agent as applied to the exposedeggshells. A formula which includes the specific characteristics of eachelement of the chicken eggs being subjected to pasteurization togetherwith their relative differences in heat sensitivity as compared to theouter albumen, including its rate of heat gain and heat loss in terms oftime and temperature of exposure to both heat and induced chilling alongwith the targeted log reduction of the targeted pathogen all areincorporated into the resulting protocol. The protocol delivers thetreated water through an optional use of a spray or mist atpredetermined intervals along with predetermined durations of intervalscontaining preprogrammed temperature changes to accommodate the subjectegg characteristics. Interruptions of the alternating applications ofsanitized and heated water in the form of a selected spray andemployment of induced chilled water containing a sanitizer applied atprogrammed alternating intervals along with the application of theheated water spray, at the end of the term called for achieves theprotection of the outer albumen from heat damage while continuouspasteurization is being performed to each of the other elementscontained within the subject chicken eggs. Those elements other than theouter albumen include the inner albumen, the vitelline membrane and theyolk, each of which requires different quantities of heat in terms ofexposure times to a selected temperature to achieve pasteurization.Through customized formulas to accommodate the individualcharacteristics of the subject eggs, the use of a unique feature commonto all formulas employed, which includes attention to the protection ofthe outer albumen from heat damage by interrupting the application ofheat intermittently through either induce chilled air or water inapplications directly to the eggshells. These features provide for thelowering of the temperature of solely the outer albumen to below 128° F.and remaining there for a specific time, which accommodates both thecharacteristics of the subject eggs and accommodates the protocolemployed, which suspends the chilling of the outer albumen when theinner albumen approaches 128° F., at which time the induced chilling issuspended. This suspension can be achieved through use of a fluidconsisting of water or air and heat disbursed through the same sources,which is applied to the outer albumen through the shells of the subjecteggs to an extent wherein the targeted pasteurization temperature usedherein as 132.5° F. is reached. The described art includes deviations inexposure times in all phases to accommodate the characteristics of thebatch of eggs being pasteurized, as well as the needs described toprotect the outer albumen from heat damage. These needs dictate the timeand temperature of exposure of each element contained within a chickenegg to achieve pasteurization of a targeted pathogen at the targetedtotal inactivation level without loss of aesthetic or loss of functionalcharacteristics as expected to be present within a raw chicken egg.Notably and of equal effectiveness, it has been learned that the use ofpurified air can be employed interchangeably with purified water toachieve equivalent results through the application of the purified airto the subject chicken eggshells employing the same shower heads readilymodified to accept air in lieu of water in its various forms. Further,approved food-grade agents to purify air being disbursed are readilyavailable to provide the same level of sanitation to the subjecteggshells as those employed for the alternative use of water. The optionprovided through the use of air requires modest adjustments easilyformulated to accommodate changes in rates of temperature changes, asinfluenced by the density differences found within air and the selectionof the water selected to be employed. The velocity of the air versus theform of water employed is a contributing factor to the formulation ofthe protocol to be employed. Since both water and air share in beingfluids, their characteristics are easily modified to accommodate theimpact of their differences upon the transfer equipment employed toaccommodate the disbursement of the heat and chilling in both formswhether air or water. Notably, each of those substances can be made moreeffective in their rate of heat transfer or in their rate of chilling,which preferably will be induced for improved control and costefficiencies, as called for and enabled under the new art. When utilizedproperly a targeted log reduction of a targeted pathogen, whether viralor bacterial, can be performed, which uniquely provides for the totalinactivation of the targeted pathogen as may be found within acontaminated chicken egg. Thus, using the elevated heat sensitivity ofthe outer albumen to reflect the benefits from its unique location, asbeing next to the heat and chilling sources through its being an abutterto the eggshell, a formula reflecting those unique characteristicsmodified to accommodate the heat transfer characteristics of thediffering densities, as found within each of the other elementscontained within a chicken egg, along with their differing locationsfrom the heat or chilling sources, in the end provide for a formulaenabling the total achievement of inactivation of the targeted pathogenswithout consequential damage to the internal contents of the chickeneggs.

As determined through the teachings learned through the experimentsemployed, the exactness of the targeted logs of pasteurization for thetargeted pathogens when achieved for each element of the subject eggswill not contain the same targeted log levels of inactivation, but ineach case will meet or exceed that targeted level of pasteurizationwithout damage to the element of the eggs receiving more than theminimal level targeted. As an illustration, the densest composition ofthe egg is found to be within the yolk. That composition combined withits most remote location requires greater exposure to heat in terms oftime and temperature to achieve the same targeted log reduction as doesthe outer albumen as one example. The formulas employed under the newart are dictated by the rates of heat transfer or heat loss as measuredby the outer albumen. Therefore, the rates of heat transfer and heatloss together with the rates of chilling as applied to the outer albumenbecome the control points of the formula for pasteurization under thenew art.

All other elements of the eggs require different levels of exposure asmeasured in time for the same temperature to produce the same resultfrom pasteurization as measured in logs. The time required for each ofthe different elements is non-exact, but in each case allows for atolerance level to be accommodated through the new formula employed,which provides for each element to benefit from the targeted logreduction but also to exceed that targeted reduction to an extent thataccommodates the other elements to achieve the same targeted level ofinactivation through longer exposure to the heat being applied withoutdelivering damage of consequence to any element requiring extra exposuretime. In the end that discovered flexibility from each element, ascompared each to the other, enables pasteurization to the targeted loglevel to occur, but in certain specific cases to exceed the targetedlevel of inactivation through greater exposure to the heat source interms of time without causing consequential damage to the moreheat-sensitive other elements within the subject egg. In summary, thediscovery of how to convert the different tolerances to heat ascharacteristic of each of the primary elements composing the chicken eggi.e. the outer albumen as thinnest in substance and most rapid in heatgain or loss, the inner albumen which is next most rapid in the samecharacteristics as found within the outer albumen, the vitellinemembrane contains within its compositional characteristics a greaterdensity in its substance than does the outer albumen, which results ingreater heat tolerance and slower rates of cooling than do both of thementioned albumens. The most dense substance, which also is the mostremote in its location, is the yolk, which requires greater time forheat gain and heat loss as compared to the discussed other elementswithin the chicken egg. Thus, the achievement of a targeted log underthe new art is available, although that targeted log may result inexcesses as measured in logs to certain elements as found within theinner albumen and the outer albumen.

The greater densities of the vitelline membrane and the yolk, allow forthe yolk to achieve the targeted inactivation, while at the same timegiving cause to both the outer and inner albumens to modestly exceed thetargeted logs without damage to the raw characteristics of thosespecific elements. This ability is made available through the new andunique cyclical application of heat and its denial, which is a keyelement of the new art described and claimed herein. As separatelydiscussed, the broader fluctuations in temperature provided to the outeralbumen enable the concurrent protection of the inner albumen and thevitelline membrane. Such is enabled by the discovery that the heattolerance of each element, once identified, can be converted into aformula which accommodates all of the differing heat tolerance levelsthrough the application of heat and its denial along with the associatedcooling. In the end, this heating and cooling creates a common result ofa pasteurization level, as measured in logs, which contains enoughtolerance through additional heat and recovery from the lack of heat toprovide an end result which succeeds in providing a targeted logreduction of a targeted pathogen. This log reduction allows for completeinactivation without damage to any one element of the subject chickeneggs, as enabled through use of interrupted applications of heat andchilling, whose durations fall within the tolerance levels of the eggcomposition to accept pasteurization without damage to the rawcharacteristics of the subject eggs beyond those which noticeably altereither the functional, nutritional or aesthetic characteristics as foundwithin raw in-shell chicken eggs.

As the evolution of both viruses and bacteria continues, the formulacontained within the new art notably and pertinently is uniquelyadaptable to increase the quantity of inactivation, as measured in logs,needed to accommodate the total inactivation of new and moreheat-resistant strains of the targeted pathogens. What has been learnedis that the described unique method and success of the inactivation ofthe mentioned viruses not only requires more heat, which under thedescribed new art is applied intermittently to avoid damage to the rawcharacteristics of each element of the subject chicken eggs throughoverexposure, but also requires achievement of a log count specific toinactivation of each targeted virus or an adaptation as made availableunder the new protocol. Thereby, the method provides for adequateprotection against differing strains of viruses through employment ofone targeted level of log inactivation capable of inactivating eachstrain of the collective strains that may exist at a given time. Thiscapability is possible, providing that the fundamental area of newinventiveness employing the application of heat and its denial, ascontrolled by the tolerance levels to both heat and rate of acceptanceand denial by the outer albumen, is not violated through the choices ofprotocol made available for achievement of new levels of pathogenicinactivation.

For certainty of understanding, the features of the new inventivenessand the new inventiveness' unique capacity to provide public safetythrough total inactivation of pathogens, as found within chicken eggs,to achieve materially greater levels of inactivation as measured in Selogs represents a notable and important part of the new inventiveness.This achievement is provided by features of flexibility to achievegreater or lesser levels of inactivation of targeted pathogens,accomplished through a unique method of employing the described cyclicalapplication and denial of heat to avoid causing material reduction ofthe raw characteristics of the subject chicken eggs as governed by thelimitations and flexibilities of the outer albumen. The number of cyclesto the application of heat and its denial both govern and enable theincrease of logs or their decrease, depending upon the targeted level ofinactivation pursued for consumer safety. The scientific communityconfirms that a 10-log inactivation of viruses as found within chickeneggs equates to 12 logs of the Se bacteria more or less.

The model employed under the new art claimed herein represents thecollective results from research information which confirms that achange in salmonella bacteria inactivation log requirement from a logrequirement of ‘5’ as authorized by the US-FDA under its Rule of 2009 to‘12’ would inactivate all viral strains which may be present to theirneeded ‘10’-log level while at the same time would be more than adequateto inactivate more heat-resistant strains of salmonella than that of Sewhich customarily has been employed by agencies of jurisdiction to bethe targeted strain of salmonella as found within chicken eggs as wellas other bacterial strains which may be present.

Various agencies have confirmed the need to raise log levels toaccommodate the inactivation of more heat-resistant strains ofsalmonella over that of Se, which have not been recognized or addressedby regulation from the US-FDA. As a result of the new knowledgeregarding relative heat resistance, 1 log was added to the equation, asdescribed herein, to accommodate the difference between moreheat-resistant strains of salmonella than Se. Independent sciencerecites specific examples of more heat-resistant strains of salmonellaas found in S. Senftemberg, S. Heidelberg, S. Typhimurium, S. Newportamong others. In the end, an initial 10-log level of inactivation forviruses is carried, which provides for a 12-log inactivation of Sebacteria. The 2-log differential for inactivation of viruses, ascompared to salmonella bacteria, stems from and is confirmed by studiesperformed by the USDA Research Laboratory located in Athens, Ga.

The uniqueness of the new art providing for levels of pasteurization ofchicken eggs is demonstrated in the first instance by its ability toeliminate risks of illness from viral and bacterial sources throughproviding total inactivation of the pathogens mentioned when present,which also preserves what may become a needed food source. In the secondinstance and as a collateral discovery, the new art achieves levels ofpasteurization for in-shell chicken eggs which maintain the rawcharacteristics of a chicken egg while providing statistically completeconsumer safety from viral and bacterial contaminants, as found or maycome to be found within in-shell chicken eggs, which never before hasbeen achieved. That new food safety achievement is the result of thetotal inactivation of all salmonella and viral contaminates whichenables their seamless conversion of safe in-shell eggs into equallysafe liquid egg product. Notably and importantly, that new discoveryends the need to limit liquid egg pasteurization to log levels measuredby salmonella, that are inadequate to provide for the total inactivationof the pathogens present, which rightfully undermines the publicconfidence in both the agencies of jurisdiction as applied to liquid eggproduct along with the public confidence in the safety of the product.Once the problem of providing safety to the public through use of safein-shell chicken eggs has occurred, the public savings through avoidanceof illnesses will convert into major reductions in dollar costs, throughthe illumination of a large quantity of illnesses stemming from chickenegg contamination. As one example, the Government identifies 45% of thepopulation as having high risks of contracting foodborne illnesses. That45% approximates 150.0 million people. The Government also reports thatchicken eggs rank as the single most source of causing foodborneillness. That statistic has been consistently reported for at least twodecades and is now compounded by the present and real threats caused byviral contamination. Further to the above, the Government confirms thatthe average cost per illness to a person of ordinary health sickened bysalmonella-contaminated chicken eggs is $20,000. Were each of the 150.0million people identified as being at high risk of illness to consume abreakfast type dish containing pasteurized liquid egg product processedat the current U.S.-F.D.A. standard for pasteurization of salmonella asmeasured by Se to a 5-log level of inactivation or even slightly higheri.e. 6- to 7-logs and such eggs were to be consumed at a frequencyequating to six (6) one (1-) egg servings, each twelve months suchstatistically rightfully would provide for a high probability that eachof the six (6) occasions could be forecasted to cause illness. Theresulting calculation of illness costs to the high risk group segment ofthe population, as identified from the Government sources recitedtogether with the minimal annual consumption by risk group membersmentioned, would produce an avoidable projected public illness coststemming from only salmonella of $18.0 trillion annually. Such issupported by performing the conversion of chicken eggs into liquid eggproduct to be made available in its various forms post in-shell eggpasteurization having occurred. Pre-pasteurization of in-shell chickeneggs before conversion into liquid egg product uniquely enables thedestruction of the real and present threat of a pandemic caused byvirally-contaminated chicken eggs along with the retention of rawcharacteristics while providing the long-needed statistical inactivationof targeted pathogens that includes all strains of salmonella as foundwithin chicken eggs and of significant importance together with thenotable benefits from providing chicken eggs free from viralcontamination which now is giving cause to forecasts of threats of majorquantities of illnesses resulting from viral contamination-causingillnesses from chicken eggs which materially contribute to the spreadand scope of illnesses of being pandemic in its proportion. Thementioned liquid egg product improvements through materially increasedlevels of pasteurization without dependency upon additives as is thecurrent protocol employed within the liquid egg product industry notablyprovides for the inactivation of both viral and salmonella strains whichotherwise unless successfully inactivated flourish within the subjecteggs particularly when co-mingled in their raw state and subsequentlyprocessed into various forms of liquid egg products.

The discovery of the differing relationships between the ingredients ofthe eggs, together with their densities and differing heat transferrates, form the basis for the first of two primary areas of discoveriesas referenced and described hereinabove. In the first instance, thosediscoveries include one which takes the mentioned differences betweenthe egg ingredients into consideration when the application of heat isperformed. That new and unique application sometimes is described hereinas being the cyclical application of heat and its denial. Thatdescription is intended to apply to the application and denial of heatat programmed intervals, which create a cycle as measured in theelevation in temperature of the subject eggs to the targetedpasteurization temperature, which for these illustrative purposes isidentified to be 132.5° F. Once having achieved the pasteurizationtemperature and equilibrium having been achieved between all elements ofthe subject eggs, the subject eggs are held there until they achieveslightly more than 1-log of inactivation of the targeted pathogen,before the temperature applied is reduced preferably by the efficienciesprovided from induced chilling. The mentioned 1 plus logs is enhanced onaverage by 20% of one log throughout the process for each time thetemperature is raised to the targeted pasteurization temperature andequally for each time the temperature is lowered from the pasteurizationtemperature to the point of beginning. After the holding time at thetargeted pasteurization temperature of 132.5° F., the outer albumenthrough the mentioned chilling solely is provided with a temperature ofbelow 128° F. The outer albumen is held at a temperature below 128° F.until such time as the inner albumen nears reaching 128° F. When thatoccurs, the heating cycle of the subject eggs is reinitiated for allelements to return to the targeted pasteurization temperature, which forthese purposes is identified to be 132.5° F., at which point a new cyclebegins. That cycle is repeated until the targeted log level has beenachieved. The described protocol concerning the outer albumen forms thebasis of the new art and enables the unique ability for the art touniquely achieve total inactivation of targeted pathogens whetherbacterial or viral without consequential damage to any portion of thesubject eggs.

For certainty of clarity and emphasis, once each element described andfound within a chicken egg is exposed to heat from either purified waterspray or from chilled purified air and equilibrium with the selectedtargeted temperature for pasteurization is reached between each element,as found within the subject eggs, the pasteurization to achieve atargeted log reduction for each element within the subject chicken eggscommences. For these illustration purposes, the pasteurizationtemperature employed is 132.5° F. While the egg is reaching its targetedpasteurization temperature, a portion of a 1-log level of inactivationis achieved. Once equilibrium between all elements contained within thesubject eggs occurs with the targeted temperature of 132.5° F., thesubject eggs reside at that temperature until an additional 1 log moreor less is achieved. To avoid overexposure to the heat provided by thementioned 132.5° F., the subject eggs then are provided with a promptreduction in either the water or air temperature, employed to an extentwhich enables the outer albumen temperature to fall below 128° F. andall other elements to remain at 128° F. or above. Such provides forcontinuing pasteurization of the other elements mentioned, albeit atdifferent rates due to their differing locations as related to the heatsource as well as their differing composition in densities, size orweight characteristics, while at the same time the outer albumen isprovided protection from overexposure from continuous heat exposure byprogrammed interruptions to the applications of heat. This protection isenabled by controlling the temperature being applied to all elements ofthe eggs, which includes induced chilling to accelerate the reductiontime taken by the outer albumen to reach the targeted lower temperaturebelow 128° F. Similarly overshooting to achieve the targetedpasteurization temperature more efficiently is a preferred option.Through its more rapid reaction to both heat and chilling, the outeralbumen quickly reacts to temperature changes and benefits from avoidingcoagulation through the protection provided by rapid temperaturechanges, which for these purposes would be from 132.5° F. to one whichcontains a temperature below 128° F. While the outer albumen findsprotection in the described lower temperature range, all other elementsof the chicken eggs continue to be exposed to 128° F. or higher, asenabled by their lesser vulnerability to heat giving cause to loss ofraw characteristics. That continuity of heat enables pasteurization tobe continuous for all elements, excepting the outer albumen. After theouter albumen has reached temperatures below 128° F., the next thinnestsubstance within the egg identified as the inner albumen will follow theouter albumen in its reduced temperature, but while doing so it willcontinue with pasteurization. The still denser elements consisting ofthe vitelline membrane and the yolk will follow the inner albumen andeach of those elements at their separate rates will continue topasteurize. Once the inner albumen reaches the mentioned 128° F., whichrepresents the lowest temperature that pasteurization occurs, theprocess is reversed to one which begins the application of heat again.Hence, the use of the term ‘cyclical’ within this Application to coverthe elevation of heat applied to a chicken egg, as followed by holdingit at that temperature for a predetermined time and reducing thetemperature to the same temperature as the beginning and holding it atthat temperature for a predetermined time before beginning the elevationof the temperature again. Notably, just as induced chilling aids inproviding economic efficiencies to the protocol described throughshortening the time taken for pasteurization targeted as measured inlogs, the same principle can be employed in overshooting the targetedpasteurization temperature referenced as 132.5° F. for theseillustrative purposes. By employing either or both overshooting thetargeted pasteurization temperature and the use of induced chilling on acontrolled basis to avoid damage to the egg ingredients, efficiencies oftime and cost are enabled through shortening the time of thepasteurization cycles which create the mentioned economic benefits. Onceequilibrium has been reached throughout each element of the subject eggsat 132.5° F., the subject eggs are held at that temperature to achievean additional 1-log level more or less of inactivation. Once thatadditional 1-log level of inactivation has occurred the protocoldescribed repeats itself. Once the targeted log reduction has beenachieved through repetition of the protocol described, subject tojurisdictional requirements, the subject eggs are cooled. This coolingoccurs preferably through the use of induced chilling either from apurified water spray or the alternative of chilled purified air, and thesubject eggs are optionally sprayed a final time with a food-gradeantibacterial agent. The antibacterial agent is drawn into thecontracting eggs through their exposed pores. These steps are thenfollowed by the application of a shell sealant, which optionally mayinclude a food-grade wax or food-grade plastic sealant or an equivalentthat may be applied through various means which include but are notlimited to a spray, bath or a roller which provides for a minimum of 95%coverage to the subject eggshells and their exposed pores postpasteurization and prior to exit from the protection of the medium. Uponcompletion of the above recited steps, post pasteurization, the subjecteggs are removed from the protected environment of the pasteurizationmedium and allowed to proceed with their protected eggshells to theirend destinations.

FIG. 1. depicts a typical section of flats containing chicken eggsprepared for pasteurization which in practice will be multiplied inquantity to accommodate production suitable to the location of thepasteurization processing facility.

The various key elements contained within FIG. 1 include:

Reference Numeral 1: in-shell chicken eggs stacked in flats;

Reference Numeral 2: flats of new and unique design providing for 95%more or less exposure of in-shell eggs to receive tempered and purifiedair or water;

Reference Numeral 3: depicts the employment of strategically locatedmultiple spray heads which service the application of either purifiedair or purified water in various forms to both pasteurize and chill thesubject eggs.

The employment of strategically-located multiple spray heads enables apreprogrammed saturation of treated air or treated water in variousforms ranging from a course spray of water to a mist which is applieddirectly to the exposed chicken eggshells. The application of water, ifselected in lieu of purified air, can be programmed to contain varyingspray densities through use of automated spray heads, which areadjustable to not only supply water with varying coarseness of the sprayof water employed but also to supply either heated or chilled watercontaining a food-grade antibacterial agent or solely a food-gradeantibacterial agent without water as the protocol employed describedhereinabove requires. If air is selected in lieu of water, in principle,the same method of application can be employed, which includes theapplication of purified air containing preprogrammed temperaturechanges, as discussed previously, in its employment to be comparable tothe protocol employed for water with minor obvious adjustments toaccommodate the density differences between substances.

The above described protocol is followed by the eggs ambiently coolingwithin the protection of the medium, during which time those eggsreceive a protective sealant, which preferably is a food-grade wax or asan alternative a food-grade plastic, applied post pasteurization andjust prior to the internal egg temperatures having achieved equilibriumwith the reduced temperature of the medium that generally will equate tothe temperature of the environment external to that of the medium. Postpasteurization, the application of a selected sealant is applied to theexposed chicken eggshells, while still within the protected environmentof the medium. The residual heat within the eggs post pasteurization andprior to their exit from the medium will be adequate to draw in throughthe exposed shell pores the protective eggshell sealant, which protectsagainst recontamination during its route from processing to table. Postapplication of the sealant, the eggs exit the secured and protectiveenvironment of the medium and enter the unprotected environment to pointof consumption, while benefiting from having been pasteurized on theinside and being protected on the outside from recontamination.

In the end, the new protocol provides the public with statisticallytotal safety from illnesses caused by either or both viral and bacterialcontamination of chicken eggs resulting from materially improvedpasteurization enabling new log levels of inactivation to be achievedwhich provide for total inactivation of the targeted pathogens.

Here follows an outline containing pertinent comments regarding theprotocol employed under the new art claimed herein, which not onlyincludes a unique pasteurization protocol but also includes thecustomized equipment which provides for a novel secured environmentwithin which the equally novel pasteurization protocol is performed.

Sequence Outline:

Prior to commencement of pasteurization, the subject eggs aretransferred into flats whose custom design includes the ability to bestacked vertically and to receive a flow of water from strategicallylocated shower heads whose spray is unimpeded by the design of the flatswhich provides for an even application of the water to flow around eachegg and to provide each egg with equal exposure to the variableadjustments of the spray water temperature being applied which willcontain a food-grade antibacterial agent at all times except only forthe exception outlined herein below. The mentioned water applied throughthe described spray may vary at times between a mist, a fine spray or acoarse spray which can be automatically alternated for time, temperatureand duration to suit the protocol being employed which may change toaccommodate the non-identical features of batches of eggs beingprocessed as well as the targeted pathogen selected for inactivationtogether with the associated variables to achieve pathogenicinactivation which is total.

Initially the stacked eggs within the customized flats prior to entranceinto the secured environment of the pasteurization medium optionallywill receive a spray of water treated with a food-grade antibacterialagent heated to a temperature which must be below 128° F. and can be aslow as 123° F. as the preferred range. That spray of water, as enabledby the strategic location of multiple shower heads together with thedesign features of the custom design of the egg flats, provide formaximized exposure to the free flow of the water together with itsfood-grade antibacterial additive which together are provided as anoption. If opted, such is performed outside the pasteurization mediumfor a prescribed time which enables the achievement of each egg and allof its particles to reach equilibrium with the elevated temperature ofthe sanitized spray water. Once equilibrium has been reached between theinternal temperature of the egg and the external spray water temperaturebeing applied, the mentioned spray water temperature, which is locatedoutside of the pasteurization medium never is reduced. That featureprovides for the expansion of the internal egg from the heat applied.Through the expansion of the internal egg invasion of externalcontaminates through the eggshell pores substantially is blocked.Pathogens either existing within the body of the eggs or trapped betweenthe outer membranes and the eggshells in material part will either beforced to exit from the pressure caused by the expansion of the internaleggs or be inactivated by the sanitizing agent contained within thementioned sanitized water applied. Under the above-described option oncethe shells have been cleansed with the spray from a shower containing afood-grade antibacterial agent and equilibrium of each internal egg hasbeen achieved with the targeted external shower water temperature, thesubject eggs promptly are transferred into the secured environment ofthe pasteurization medium. In each instance the invasion of airbornepathogens materially will be reduced and the concentration of survivingpathogens being carried within the chicken eggs into the securedenvironment of the pasteurization medium correspondingly will be reducedunder this optional pre-pasteurization protocol preparation. The overallbenefit achieved from the optional employment of the external shower isto reduce the quantity of pathogens present upon the eggshells stemmingfrom their having multiplied into quantities resulting from the timemade available from the date of lay to the date of the rinsing process,which frequently enables multiplication of the targeted pathogens tobecome excessive. The described shower provides for the benefit of thequantity of contaminants present upon the eggshells being reduced, butnotably are not eliminated through the application of the describedshower containing a food-grade antibacterial agent. All of the aboveprotocol is optional to aid in reducing the level of contaminationfrequently existing upon un-cleansed eggshells prior to entrance intothe secured environment of the pasteurization medium. Notably andfurther to the above, the treated water employed for the rinsing processcan be substituted by the use of similar temperatures applied to thesubject eggs employing adjustments to accommodate the use of food-gradepurified air in lieu of the referenced food-grade purified water. Suchwould be followed by pasteurization within the referenced safeenvironment of the medium.

The second new area of primary inventiveness is found to be within a newand unique pasteurization medium created for pasteurization of in-shellchicken eggs with the specific purpose of providing both housing for themechanics for pasteurization to be performed within a self-sufficientenvironment. This medium protects against external contamination and issecure from violation of that security throughout the duration of theequally unique pasteurization protocol being employed as describedhereinbefore, which achieves total inactivation of pathogens that may bepresent at high cell count levels stemming from either or both bacterialor viral sources.

Once within the isolated environment of the pasteurization medium, whichcontains novel security and continuous purification features that aredescribed in greater detail in this same section hereinabove, the eggsreceive continuous and varied protection against contamination orrecontamination provided to the subject eggs through the optional use ofa shower containing a food-grade antibacterial agent, whose temperatureis programmed to vary from a preferred pasteurization temperature of132.5° F. to temperatures below 128° F., which is below the effectivepasteurization temperature range. Such water temperature changes occurat prescribed and programmed intervals. All of the above waterapplications together with their temperature changes and approvedfood-grade additives for perpetual purification during processing arereplaceable with only modest alterations with purified air. The targetedlog levels inactivate the more heat-resistant viral strains over thoseof salmonella strains as may be or come to be found within chicken eggs.In the end, these targeted log levels provide for inactivation of thementioned pathogens without consequential reduction of the nutritionalvalue of the chicken egg or the loss of or reduction to their rawcharacteristics whether aesthetic, functional or nutritional benefits.During the described process, the use of redundancy of differenttemperatures held for different intervals within the temperature rangeto and from below 128° F. and 138.5° F. is both programmed and employedto ensure that the targeted log reduction representing totalinactivation of the targeted pathogens has been achieved without heatdamage to any one element of the subject chicken eggs. For certainty ofclarity and understanding, the ability to inactivate targeted pathogensthrough achieving log level counts never before accomplished, which inthe end succeed in achieving their total inactivation without causingheat damage to the subject eggs is made available through the protocolof the new art described. Thus protocol provides protection against heatdamage i.e. the beginnings of cooking of any or all elements of thesubject eggs through the use of intermittent interruptions of heat andthe intermittent interruptions of induced chilling employed atpredetermined intervals and durations all of which are performed withina new and unique protocol described and claimed herein. The new protocolrecognizes and utilizes not only the natural order of the differingelements within the composition of the eggs, which include from theshell inward the outer albumen, the inner albumen, the vitellinemembrane and the yolk. This protocol also employs the new and uniquepasteurization formula, which provides for the protocol enabling thetotal inactivation of targeted pathogens that include numerous strainsof salmonella as found within chicken eggs and the more current arrivalof viruses which continue to threaten both birds and eggs with viralcontamination. Science has confirmed as reported herein elsewhere thatviral contamination requires greater heat to inactivate than doessalmonella. Since chicken egg pasteurization has targeted salmonellaonly and has failed to totally inactivate all strains as found within achicken egg without loss of raw characteristics of the subject chickeneggs, inadequate pasteurization has been practiced for decades primarilyupon liquid egg products, which evidence shows over that period of timethat practice likely has sickened tens of millions of people. Thechallenge for a totally effective protocol of pasteurization to resolvethe inadequacies of a 5-log protocol of inactivation of salmonella, asmeasured by the Se strain as found within chicken eggs now is magnifiedby the need to take pasteurization to a still higher level. This higherlevel is required to inactivate viruses, which require according toscience a general need for 2 logs greater than does salmonella foreffective inactivation. The new art has the flexibility to achieve totalinactivation, i.e. 10 logs, as applied to viruses, and 12 logs asapplied to bacteria, when being pasteurized at the same time. Weremutations to create a greater need for higher levels of inactivation,the new protocol claimed herein can be expanded to manage theinactivation of new strains requiring such.

The new art reflects the discoveries made concerning the relationshipsbetween the individual densities of the elements contained within achicken egg, as such relate to heat tolerances and rates of heattransfer, as further impacted by their relative location to theeggshells. The eggshells are the first locations of the heat beingapplied externally to the subject eggs. The internal contents of thesubject eggs and their specific locations provide for the basis of a newformula for pasteurization. This formula enables a new ability toutilize the differing densities and the individual locations of thecomponents, as found within the subject eggs containing different levelsof heat sensitivity as well as different rates of heat transfer,resulting in new art that satisfies the total inactivation of thetargeted pathogens without consequential damage to any one of thementioned elements contained within the subject chicken eggs.

Once the above-described protocol has been performed and the targetedpathogens to be inactivated has occurred and while the subject eggs arewithin the protection of the secured environment of the mentionedmedium, the shells of the pasteurized eggs are treated with a finalspray containing solely a food-grade antibacterial agent. That agent isdrawn into the subject eggs through the exposed eggshell pores, postsubstantial pasteurization having occurred, while the internal egg iscontinuing to contract due to ambient cooling occurring postpasteurization while still within the protected environment provided bythe medium. The contraction of the egg while within the safety andpurity of the new and unique medium draws into the eggs through theirexposed shell pores the food-grade antibacterial agent which provides afinal level of security to the subject egg purity achieved from thetotal inactivation of pathogens through the new pasteurization protocolemployed. If any agency of jurisdiction outside of the United Stateswere to disallow the application of the described antibacterial agent tothe eggshells post pasteurization employing either air or water as themedium, that added step of precaution intended to inactivate any straypathogens either can be replaced with a non-liquid agent or eliminatedaltogether. While still within the protected environment of the mediumand while contraction of the internal egg is still in process due toambient cooling post substantial pasteurization having occurred, theshells of the subject eggs are provided with a food-grade sealant whichcan be either a wax or a food-grade plastic sealant applied to theeggshells and their exposed pores. Notably, the residual heat duringambient cooling while within the protected environment of the mediumdraws the selected sealant as applied to the eggshells into the exposedpores of the eggshells, after which, post reaching ambient temperaturewith the temperature within the medium, the eggs are exited forpackaging and shipment.

As is more fully detailed hereinabove, within the description of the newart, which employs pasteurization protocol options of performingpasteurization through either a water based pasteurization protocol orthrough an air based pasteurization protocol enabled by modest andstraight forward modifications, which incorporate the benefits of theunique features contained within the self sufficient and protectedenvironment of the pasteurization medium as modified to accommodate thefluid selected for pasteurization which in each case will provide forthe total inactivation of all pathogens as found or may come to be foundwithin chicken eggs through the employment of the new protocol.

Notably and significantly the above described protocol, together withits performance within the uniquely appointed medium, enables abreakthrough to the art of creating pasteurized liquid egg productcurrently allowed by regulation to be performed at a known to beinadequate 5-log level of inactivation of salmonella as measured by Se.the effectiveness of pasteurization is improved to a level providing fortotal inactivation of all strains of salmonella, as found within chickeneggs, together with the total inactivation of viruses, which areforecasted to likely become found within chicken eggs. Such isaccomplished by first pasteurizing the subject chicken eggs within theirshells to a level which provides for total inactivation of the mentionedpathogens, which is accomplished while retaining essentially all of theraw characteristics of the subject chicken eggs which postpasteurization under the new art can be converted into liquid eggproducts containing equal raw characteristics to those liquid eggproducts currently employing a substandard 5-log level of inactivationof Se.

The above recitation addresses the pasteurization inadequacies of allprior art to inactivate salmonella, as found within chicken eggs, which,in the end, confirms the need for termination of avoidable public riskcaused by salmonella-contaminated chicken eggs, which presently remainsto be the single most cause of illness as found within all food groupsas reported by US Government agencies. Those reports of illnessquantities resulting from the consumption of raw in-shell eggs, whetherconsumed in their substandard form, which may be the results ofmislabeling or untimely distribution together with the inadequacies of a5-log pasteurization, whether provided to the public through in-shelleggs or their conversion into liquid egg products, in each caserepresents a serious and costly set of misrepresentations to the publicwhich has spanned decades.

Notably and more dangerously, viruses and their derivatives carry withthem more heat-resistant strains of the Avian Influenza virus, whichboth require greater heat inactivation than do all strains of salmonellaand are expected to continue their already present indications toachieve the ability en masse to enable human-to-human transfer givingcause for a pandemic to be forecasted as confirmed by both thescientific community and WHO.

The described new art through its novel features provides for what iseffectively considered to be total inactivation of viruses throughachieving a pasteurization level providing for a 10-log level ofinactivation of all strains of viruses likely to be found within achicken egg which includes the most dominant strain identified as theH5N1. The USDA Research Laboratory in Athens, Ga., confirms that Seinactivation at the same time and temperature exposures as that of theH5N1 virus produces up to a 40% greater inactivation of Se than does thesame exposure as applied to the H5N1 virus as measured in Se bacterialogs. Since it requires 10 logs to inactivate the H5N1 virus withscientific certainty, such would produce an equivalent of a 12-loginactivation of Se automatically to occur. Notably, were either virusesor salmonella bacteria to evolve into more heat-resilient strains thatrequire greater log reduction than 10 logs as applied to viruses, thedetails provided concerning the capabilities for expansion of levels ofinactivation described under the new art will accommodate those needs.This feature is due to the new art's ability to use the features of thecyclical applications of heat and the applications of induced chillingwhether in each case through the interchangeable use of water and airwithin a protocol, which prevents coagulation of the subject eggs butproduces total inactivation of the targeted pathogens throughrepartition of the above referenced and mentioned cyclical process.Through the mentioned protocol, which describes applications of heat andchilling alternating in what is described as a cyclical manner withinthe prescribed protocol, employing the application and denial of heatlog levels of inactivation of both viruses and bacteria representingtheir total inactivation are achieved while uniquely preserving the rawcharacteristics of the subject eggs. Notably, under the new art ofimproved pasteurization, the subject eggs preserve their raw eggcharacteristics and retain their nutritional benefits, which can beprovided to the public as either a safe in-shell chicken egg retainingits raw and nutritional benefits or be employed in conversion intoliquid egg product, enabling that product for the first time in itshistory to rightfully make a claim of reliable safety. The details ofthe application of the heat and its denial referenced as cyclical innature have been more fully described herein before in this samesection.

For clarity of understanding, the importance of the discovery of thebenefits gained from the novel use of a programmed application of heatand its denial as employed during pasteurization in a manner termed tobe cyclical in its nature enables the prevention of heat damage to eachelement of the internal egg. At the same time, the new art provides forthe total inactivation of targeted pathogens to be achieved withoutmaterial loss of the raw characteristics of the subject eggs whilenotably achieving log levels of pathogenic inactivation never beforeavailable without loss of the raw characteristics of the subject eggs.That accomplishment now is restated for emphasis and clarity.

Summary and Conclusions:

The US-FDA as preceded by the USDA traditionally allowed eggscontaminated with a virus identified as the H3N1 to be pasteurized tothe equivalency of a 4-log level of inactivation using the bacterialstrain of Se as the measure when found within chicken eggs that wereintended for uses specific to liquid egg product. Under the Egg SafetyFinal Rule adopted in 2009 the mentioned 4-log inactivation protocol asapplied to the bacteria strain Se was increased to 5 logs which wasintended to use Se as representing the level of inactivation for allstrains of salmonella as well as all levels of contamination ofsalmonella as may be found within all chicken eggs which included bothliquid egg product and pasteurized in-shell chicken eggs as they mayoccur. That determination clearly implied that no meaningful level ofcontamination of a chicken egg occurred beyond that as may be foundwithin the specific strain of salmonella identified as Se. The FinalRule did not address viral contamination at all. The inadequacy of a 5log level of inactivation of Se as the salmonella strain of measure toprovide safety to a public consuming less than hard-cooked chicken eggsand believing in their safety as generated by the term ‘PASTEURIZED’ asdisplayed on the egg cartons together with the USDA shield alsodisplayed on the egg cartons which in both cases were reinforced by theabsence of the ‘Safe Handling Instructions’ to be displayed on allunpasteurized shell egg cartons by requirement now needs the inclusionof viruses to be added to the ‘Safe Handling Instructions’ to representa totally new threat to the public health which may grow to be pandemicin its proportion. The justification for the inclusion of viruses withinthe mentioned Safe Handling Instructions is to provide a continuingrecommendation that hard-cooking not only successfully replaces lack ofpasteurization but also protects against the inadequacies of currentlevels of pasteurization to inactivate viruses which represent arecognized threat to the public to be delivered by a pandemic causedfrom the avian influenza virus.

Notably and significantly the described new inventiveness for the firsttime enables the total destruction of all known to exist salmonellastrains as found within chicken eggs which under the new inventivenessrenders them statistically inactivated through achievement of log levelsnever before actually demonstrated to have been achieved and reduced topractice while at the same time materially exceeding the currentexisting targeted level of a 5-log destruction of Salmonella enteriditisas set by the US-FDA as being sufficient for salmonella inactivation ascarried within the language of the Egg Safety Final Rule of 2009 whennone such safety can be assured. Under the new art the improved level ofinactivation as measured in logs is available to destroy all of the moreheat-resistant strains of bacteria than Se as found within S.Senftemberg 775 W, Heidelberg, Typhimurium, Newport and Javiana as but afew examples of strains of salmonella found within chicken eggs whichrequire more heat than Salmonella enteriditis (Se) for theirinactivation which within Se itself carries with it sub-strainsrequiring higher inactivation than does the primary strain identified asSe. Said differently the use of Se as the measure for inactivation ofsalmonella on its face according to science requires materially morethan 5-logs as set by the US-FDA under the new Rule of 2009.

Notably and of related importance sterilization of a chicken egg willinactivate pathogens but at the cost of the loss of nutritional values.It is pertinent to note that pasteurization preserves both thenutritional benefits and the raw characteristics of a chicken egg evenwhen pasteurized at 12-logs as is made available under the new artdescribed herein which inactivates all strains of salmonella known to befound within chicken eggs as well as those viral strains which havecurrently been found within chickens and may come to be found withinchicken eggs in the future. The forecasted pandemic as provided byexperts within the field of viral contamination as of 2015 confirms thatsuch would result from viral strains entering chicken flocks and theirresulting eggs which raises the probability of causing massivequantities of illnesses to occur from the natural spread of the virus tohumans which materially would be magnified by one mutation enabling thetransfer of illness to occur from human-to-human as is confirmed byselective cases already having occurred in separate geographies rangingfrom Europe through Asia. Even in the absence of a mutation whichenables human-to-human transfer the foundation for a pandemic caused byAvian Influenza as may come to be found within chicken eggs remains tobe an international public health threat of pandemic proportions asconfirmed by world experts including the World Health Organization.

In the instance of new strains of viruses such carry with them a new andunique threat to public health not previously experienced from chickeneggs. As found under the H5N1 virus its potential ability to transferserious and frequent fatal illnesses occurring from human-to-human hasgiven cause for the scientific community to forecast that throughmutations or deviations from the mentioned H5N1 it can be reliablyforecasted that such will give cause for either one of or part of a baseviral source to convert into an aggressive viral source which willprovide for the rapid and broad transfer of illnesses fromhuman-to-human which in the end creates the already confirmed arrival ofthat virus as being the foundation for a pandemic whether throughhuman-to-human transfer of the virus or whether through the common areasof exposures to the public at large. The described deficiencies ofcurrent chicken egg pasteurization protocols employed to inactivate thetargeted bacteria selected using Se as the measure employed whencombined with the greater levels of inactivation of salmonella requiredto inactivate viral strains once considered together reconfirm thewarnings provided by WHO that the public at large is exposed toillnesses from Avian Influenza, and the forecasted pandemic resultingfrom both the virus continuing to evolve and the vaccine developmentbeing incomplete due to the continuing evolution of the virus togethergive cause for the government agencies of jurisdiction to be delayedfrom resolving the issues encountered in the process of trying toprotect the public health to be likened to that of a moving target. Thenew art disclosed and described herein contains a unique protocol whicheliminates the above mentioned dilemma of a threat to public health ascaused by the portion of that threat contributed to by virally andbacterially contaminated chicken eggs. The new health threats fromviruses which exceed in their magnitude the health threats of thosealready existing from bacteria as found within chicken eggs areconfirmed through reports provided by the international scientificcommunity which are reconfirmed through forecasts from the World HealthOrganization that a pandemic containing viruses and labeled as the ‘BirdFlu’ is within the making as enabled by more heat-resistant viruses nowidentified to be carried by chickens as illustrated by the presence ofthe H5N1 virus among other virus strains now confirmed to exist andcontinuing to evolve. Those viruses together with their deviations mayprovide for human-to-human transfer of illness. Although viruses areheat-sensitive those associated with chickens and their eggs requiregreater heat than prior art can deliver to achieve inactivation withoutloss of raw egg characteristics. The new art claimed herein disclosespasteurization to be available at log levels without damage to the rawcharacteristics of the subject chicken eggs which provides forinactivation of both salmonella bacteria in all strains as known to befound within chicken eggs as well as all strains of viral contaminationas may come to be found within chicken eggs as identified and confirmedby the USDA Research Laboratory in published reports on that verysubject area. Were a pandemic to occur the new art referenced andclaimed herein will enable chicken eggs to be used for a needed safefood source while at the same time eliminating those chicken eggs frombecoming carriers of contamination and to further magnify the scope ofthe pandemic.

As discussed in greater detail within this section hereinbefore, theinitial step employed within the pasteurization medium involves theselection of the vehicle to transfer heat or chilling to the subjectin-shell eggs being pasteurized. The selections include the use of awater bath treated with a food-grade purifier, which is not thepasteurization medium of preference. The preferred options include usesof a water spray treated with a food-grade purifier, which is equallypreferred with the use of air also treated with a food-grade purifier asthe medium to transfer air through nozzles similar to those employed forwater. In each case, the selected vehicle contains induced heat andinduced chilling carried to the subject in-shell chicken eggs throughemployment of a new and unique protocol. This protocol contains theapplications of both heat and chilling at preprogrammed temperatures forpreprogrammed intervals and durations applied to the subject in-shellchicken eggs, which deliver at the end of the protocol selected chickeneggs that contain a level of pasteurization which both are free oftargeted pathogens and have retained substantially all of theiraesthetic and functional raw egg characteristics. The shower containingeither sanitized water or sanitized air is performed at prescribedintervals for prescribed temperatures and durations, within the confinesof the protected environment provided by the medium. The temperaturesinitially of the water or air being applied always will be elevated intheir initial application to be above the temperature of the subjecteggs upon their receipt into the medium. Both options of the referencedshowers will contain a food-grade antibacterial agent to ensure thatwater and air purity are maintained for continuous inactivation ofpathogens which may be present. Unlike all forms of water rinsesgenerally practiced in the United States, the water circulated throughthe mentioned showerheads will be continuously cleansed duringrecirculation. The mentioned water employed will contain the option tobe in the form of a spray or a mist. The precaution of the internal eggtemperatures being equal to or slightly lower than the temperaturewithin the medium at time of entrance is required to protect againstresidual pathogens present from accelerating their multiplication withinthe new and secured environment provided by the medium.

The protocol recited above, together with the mentioned featuresconcerning perpetually circulating purified water which may besubstituted with similarly treated purified air, is provided to theexposed chicken eggshells within the secured and perpetually sanitizedenvironment provided by the pasteurization medium. The protocol isfurther enhanced in its effectiveness by multiple layers of filtration,heat and ultraviolet treatment, along with a food-grade antibacterialagent continuously applied to the purified water or air throughout thepasteurization processes of each batch of eggs. All of the recitedoptions, protocol employed, features of the medium and the controlledintermittent applications of heat together with induced chillingcollectively are unique to the new art, which ensures total inactivationof targeted pathogens, retention of both nutritional and rawcharacteristics of the subject eggs and the preservation of the benefitsof pasteurization achieved from risks of recontamination of the subjecteggs from pasteurization through table as enabled and reinsured by theuniquely secured environment of the medium.

The temperature within the shower serviced by purified water or asemployed by its air alternative is to be controlled for accuracy of bothtime and temperature through continuous monitoring of the internaltemperatures of the subject chicken eggs, which include the outeralbumen, the inner albumen, the vitelline membrane, the yolk and the airsack, to ensure that variations caused by the environment of the subjecteggs together with their sizes, i.e. weight, together with differingimpacts upon the subject chicken eggs in their receipt of heat orchilling applied in ratios preprogrammed for the art described hereintogether with adjustments called for by differences found within wateror air temperatures and exposure times to those temperatures. Thesevariations satisfy the peculiarities of egg sources that include but arenot limited to size, diet, water consumption, altitude and other factorsunderstood by those skilled in the art. As the expansion of the eggcontent occurs during pasteurization, certain targeted pathogen cells,whether inactivated or not, are forced out from the egg through itspores into the environment of the medium. At this point, continuedinactivation is provided through built-in protective provisionscontained within the medium, which create the inactivation of targetedpathogens through exposure of the residual pathogens to ultraviolet, dryheat and food-grade anti-pathogenic agents applied directly to theeggshells. Notably and specifically, post the subject eggs havingachieved substantial pasteurization through use of either purified wateror purified air, depending upon the protocol selected, and only afterpasteurization has been substantially completed in achieving thetargeted log level for inactivation of the targeted pathogens whileremaining within the protected environment of the medium, the subjecteggs optionally can be relocated within the medium to a separate areawithin the medium. In either case, the eggs are provided with a showerof water or air containing the selected food use approved bactericide oralternatives which may be more appropriate for viral contamination. Asan option to purified water and of equal merit for the eggs beingprocessed, the use of purified air containing a selected food useapproved bactericide can be employed. Under either protocol, the fluidchoice selected to be used within water or air may require approval forfood-grade use together with the ability to inactivate the targetedpathogens whether bacterial or viral. After the subject eggs havereceived the mentioned application of the agent selected and areambiently cooling, the continued contraction of the subject eggs drawsthe mentioned agent into the eggs through its exposed shell pores, whichprovides for additional protection of both the pasteurization resultsand reinforces protection against unexpected anomalies causingrecontamination to occur. Post receipt by the eggshells and theirexposed pores of the above mentioned agent selected, the subject eggswhile continuing to contract internally from residual heat and prior totheir exit from the protection provided by the medium, receive a sealantto the eggshells and its pores consisting of either a food-grade wax ora food-grade plastic as the preferred sealants. That described finalstep of providing the sealant to the subject eggshells, as performedwithin the medium, protects the subject eggs from a contaminatedenvironment, which always is a factor present for unprotectedpasteurized eggs being exposed to environments which commonly arecontaminated to an extent which over time would void the benefits ofpasteurization.

Notably and materially, the above described protocol provides forequally effective variables within a common protocol to employ eitherpurified water or purified air as the vehicle of choice to provide forboth the application of heat and chilling of chicken eggs to achieve thesafety provided through levels of pasteurization which in the end aretotal. Where agencies of jurisdiction are concerned with the employmentof water in any form to either cleanse eggshells or to employ a waterbased pasteurization protocol, air can be optionally utilized togetherwith its purification and ability to carry with it the transfer of heatto both pasteurize and to purify the air from contaminants along withother described agents which too are not water dependent. Cleansed airprovides for an end product, which not only extends shelf life to begreater than un-refrigerated, un-cleaned eggshells and the results fromunwashed and un-refrigerated eggs, but also ensures protection againstthe natural inclination of the public storing eggs that are unwashed andnot fresh longer than is appropriate before consumption. Notably, thenew art satisfies the recited concerns over the employment of water inany form associated with chicken eggshells. The new art also providesfor superior safety from current bacterial risks, as found to be presenton eggshells, and safety from their transfer into both the eggsinternally through the passage of time, which is enabled by thedeterioration of the natural sealant provided to the eggshell pores,which usually occurs in 10 days or less. In certain jurisdictions a5-log level of inactivation of bacteria, when present within an egg orupon its shell, has been deemed to be sufficient to provide publicsafety to consume less than hard-cooked chicken eggs. The bacteria ofmeasure in the United States is salmonella in the Se strain. The new artdescribed and claimed herein achieves the true inactivation level of allstrains of salmonella, as now is known to be found within chicken eggswith the possible but unreliable exception of chicken eggs which areunwashed, un-refrigerated and consumed promptly. The new art describedherein initially targeted a 10-log inactivation level of salmonella andsucceeded in doing so without loss of nutritional, aesthetic or rawfunctional characteristics, which matched United States Governmentstudies concluded in the 1970's intended for liquid egg product safety.The new art described herein not only provides for protection againstrecontamination during or post pasteurization but also provides forlevels of excessive pasteurization which inactivates viruses. No othersolution to chicken egg contamination from either bacterial or viralsources exists, except as found within the new art claimed herein orthrough hard-cooking. Notably the new art provides an option to employeither water or air in a secured environment to achieve the targetedlevel of inactivation needed for not only normal levels of contaminationof salmonella as found within chicken eggs but also materially hirerlevels commonly found to be present within chicken eggs contaminated byvarious salmonella strains which readily multiply into tens of millionsof cells when un-refrigerated in a matter of 30 days. The new found riskfrom viruses requires generally a 20% greater level of inactivation thandoes salmonella. The new art optionally can be programmed to inactivateboth pathogens totally while retaining substantially all of thenutritional, aesthetic and functional characteristics of a fresh and rawchicken egg.

Anecdotally, under prior art, the eggs post pasteurization, as performedwithin a treated water bath, were transferred out of the bath onto aconveyor belt. The time of transfer averaged approximately 3 minutes.After transfer onto a conveyor belt, the subject eggs promptly wereprovided with a spray of an antibacterial agent to avoid airbornerecontamination. During that mentioned 3 minute period, within which thesubject eggs were exposed to an external environment containing asignificant negative atmospheric pressure change, most of the eggsbecame recontaminated from airborne salmonella contamination. Thescientific community at the time doubted that the source ofcontamination was airborne, but subsequent testing reconfirmed what wasthen considered to be an experience which was an anomaly. The securedenvironment provided under the new art to perform all phases ofpasteurization from inception through application of a protectivesealant post pasteurization completion under the new art describedherein is performed within a uniquely self-sufficient, self-cleansingand secured environment which avoids all avenues of inadequatepasteurization and all areas of potential recontamination. Of particularimportance, the inventive features include protection of thepasteurization level achieved from both external contamination postpasteurization and at the same time provides for the performance ofpasteurization not only using unique protocols but also using equallyunique equipment which includes new flexibilities to the equipmentcontained within a medium within which the transfer of heat together nowwith induced chilling is provided.

To better understand the significance of the discovery of the benefitsderived from the creation of a new medium for pasteurization containingself-sufficiency, required security and an environment within which thenew and unique protocol for pasteurization of in-shell chicken eggs isperformed, the following described failures under prior art of this sameinventor is provided.

First, the targeted level for pasteurization of in-shell chicken eggs,as provided to this inventor by senior officials at the US-FDA in 1997,was that a 5-log reduction of Salmonella enteriditis (Se) as may befound within in-shell chicken eggs. That level of pasteurization asrepresented to this inventor who eventually performed such in allrespects enabled the in-shell egg carton to display the term‘PASTEURIZED’ and to abandon the display of the term ‘Safe HandlingInstructions’ together with its language displayed on unpasteurizedin-shell egg cartons which advised in specific terms that chicken eggsmay cause illness if not hard-cooked and more particularly identifiedthose persons who are members of the high risk groups.

Second, the level of pasteurization originally set for liquid eggproduct in or 1970 was 10-logs. Sometime subsequent to that date thelevel of inactivation of salmonella within liquid egg products beingproduced through passage within a heated tube was relaxed to 4-logs toaccommodate liquid egg product producers who were having difficulty withcoagulation while pasteurizing co-mingled chicken eggs converted intoliquid form. That relaxation never was provided to the public nor thisinventor even though that relaxed standard was in place for nearly twodecades before the above-mentioned request for a level of pasteurizationfor in-shell eggs was made and provided by the US-FDA to be at the abovementioned 5-log level.

The consequences of the above are reflected within the US-FDA Egg SafetyRule of 2009, which altered liquid egg product inactivation ofsalmonella from the above mentioned 4-logs to 5-logs which equated tothat which was provided for in-shell eggs. That level of inactivationcontinues through the date of this writing.

As noted more fully elsewhere hereinbefore, various practices continuewhich threaten public health in magnified amounts over that which wouldoccur from inadequate pasteurization at 5-logs of contaminated chickeneggs were such to be practiced in otherwise good faith. Nonesuch goodfaith practices have occurred.

Specifically, two Grade B eggs are allowed in each dozen of so markedand so displayed with the USDA Shield which confirms that the subjecteggs have been as Grade A eggs.

Further to the above, unsold eggs are allowed to be repackaged and to beprovided with a Grade A symbol to replace the same symbol on the priorpackage and are allowed to have a new “Best By’ date which generally isrepresented to be 30 days post packaging. Such enables a minimum ofbetween two and three months from date of lay through to the last day ofthe ‘Best By’ date represented.

Still further, the average number of eggs produced within the UnitedStates annually exceeds 8 billion dozen of which somewhat more than 2billion dozen are converted into liquid egg product. The new US-FDA Rulereferenced above allows for known to be highly contaminated chicken eggsto be co-mingled into liquid egg product once pasteurized to a 5-loglevel of inactivation as measured by Se. As mentioned hereinbefore, theoriginal standard for inactivation of salmonella was set at 10-logs andno science since has justified a correction to that standard.

Further to the above, new teachings confirm that the quantity andconcentration of salmonella bacteria which now includes viruses duringthe application of the heat utilized for pasteurization together withthe resulting expansion of the internal egg content give cause to thosepathogens to escape from within the subject chicken eggs through theshell pores and to become airborne in significant quantities notpreviously either known to or expected to occur as has been confirmed byexperts within the scientific community. The negative atmosphere commonto egg processing facilities frequently has been found to beinsufficient to discharge the volume of salmonella cells being generatedfrom the commercial scale egg grading and washing section in combinationwith the pasteurization being performed. Post pasteurization of in-shellchicken eggs, the air contained within the processing environmentfrequently became overrun by the quantity of salmonella cells beingdischarged from the pasteurization process which gave cause to providean inability of the negative atmosphere employed within thepasteurization area to successfully discharge the quantity of salmonellacells that had become airborne. Once the mass of pasteurized in-shellchicken eggs began contracting post their heat treatment through, eitherambient or induced cooling, their collective contraction created an aircurrent enabling the free floating airborne salmonella cells to beattracted to the eggshells along with their exposed pores which in theend gave cause for each and every egg to be at risk of having salmonellacontamination. That phenomenon now is found to be applicable to viralcontamination since the eggs being pasteurized target both salmonellaand viruses. That new knowledge resulting from Government studies haschanged the frequency of risk of salmonella contamination currentlyfound within chicken eggs to be from one egg in 3,600 eggs ranging toone egg in 20,000 eggs depending on the level of salmonella cells foundi.e. one egg in 20,000 eggs representing the least in frequency buthaving the most serious health consequences. Prior art forpasteurization never has achieved either reliable total inactivation ofhighly salmonella contaminated chicken eggs, nor have protectivemeasures such as reliance upon uninterrupted deep chilling successfullyprovided public protection. Such directly as well as by indirectreferences is confirmed by Government studies which recently reconfirmthat both salmonella caused illnesses from under cooked chicken eggsremains to be the leading cause of food-borne illness in the UnitedStates, and reconfirmation from similar Government agencies of standingexists that one egg in 20,000 eggs remains to be contaminated givingcause to illnesses which continue to occur at the same long-standingrate of frequency. Under the prior art employed for pasteurization ofin-shell chicken eggs a phenomenon occurred which resulted from in-shelleggs internally expanding as caused by the heat being applied to achievepasteurization. That expansion caused inordinate quantities ofsalmonella cells present within the subject eggs and upon the subjecteggshells to become airborne under the pressure of the expansion of theinternal eggs en mass. The quantity of salmonella cells airborne weretoo great for disbursement by negative atmospheres employed even whenaided by exhaust systems. The result was and may continue to be that agreater percent of the subject eggs became contaminated from the eggspost-pasteurization collectively contracting internally and creating acurrent drawing the airborne salmonella cells back onto the exposedpores of the eggshells post-pasteurization which created moresalmonella-contaminated eggs than existed had pasteurization not beenprovided at all. Under the new art claimed herein, a primary area ofinventiveness is found within the medium described, which resolves theunfortunate discovery previously experienced under prior art thatairborne recontamination of eggs was inevitable unless new measures ofsecurity were to be employed. Specifically those measures to be employedwould require addressing of the quantity of airborne bacteria presentdespite prior countermeasures employed which included negativeatmosphere and prompt chilling post-pasteurization. Those issuesremained unresolved under prior art as found within the patent issued tothis same inventor identified as the U.S. Pat. No. 6,692,784 B2. Theproblems of recontamination described herein above together withinadequate pasteurization of salmonella through an art employing atarget of a 5-log level of inactivation as represented by Se iscompounded as a public health risk when the pasteurization protocolwhich currently exists is faced with the need for inactivation of allcells of salmonella stemming from all strains of salmonella as furthercompounded by the now present viral strains requiring greater levels ofinactivation as measured in logs than do salmonella strains for theirtotal inactivation which no present art employed commercially achieves.

The first of the two primary areas of inventiveness is described to be‘cyclical’ in its nature. That term is applied because it is apt to thenew art that provides for the application of heat and its denial in aprogrammed manner which is unique. Specifically, the new art providesfor the application of heat to in-shell chicken eggs which raises eachelement internal to the subject chicken eggs to a predetermined targetedpasteurization temperature. Depending upon the tolerance level of theouter albumen to the heat applied the subject eggs are held at apredetermined temperature identified as the pasteurization temperaturelong enough to achieve partial pasteurization but short enough to avoiddamage to the outer albumen. Once that time frame has been establishedto suit the peculiarities of the subject eggs as influenced by size,water content and other considerations discussed herein before the eggtemperatures are lowered to protect the outer albumen which contains thegreatest heat sensitivity and the greatest rate of heat loss. The outeralbumen of each egg gains that protection from temperatures below theminimum pasteurization temperature of 128° F. For reasons discussed ingreater detail herein before, the other elements of the chicken eggs dueto their locations being more remote on a graduated basis from the heator cooling sources being applied on a programmed basis do not requirethe same level of protection from heat damage as does the outer albumen.Notably, when heat is applied to an in-shell egg the outer albumen isthe first element achieving an inactivation level involving the targetedpathogens. The other elements of the chicken eggs are slower than theouter albumen to react to both heat and its denial which includes bothinduced chilling and accelerated heat gain. By applying heat to allelements of the eggs and discontinuing the application of heat onceequilibrium between all elements within the chicken eggs and thetargeted pasteurization temperature have occurred the chicken eggs areheld at that temperature depending upon their individual characteristicsfor a period of time, most often producing a 1.0- to a 1.75-logreduction of the targeted pathogens which is expected to be a virusrequiring a greater number of cycles for their inactivation than thoserequired to inactivate current strains of salmonella bacteria whichrequire a lesser level of inactivation than viruses but approximatetwice that which currently is being employed and endorsed by regulation.After the inactivation level has been calculated into time required foreach cycle mentioned such is divided into the selected log level ofinactivation targeted which once employed provides for totalinactivation of the targeted pathogen.

The above-described protocol, when employed in the following sequence,creates a description of the novel method employed for pasteurization ofin-shell chicken eggs through use of the unique characteristics of theouter albumen to provide for the parameters to be employed through theapplication of heat and its denial through which from repetition a cycleof events that includes in the order of their occurrence raising theinternal temperatures of the subject eggs to a targeted pasteurizationtemperature and holding that achieved temperature for a prescribed timeas governed by the heat tolerance level of the outer albumen which isfollowed by the lowering of the temperature of the outer albumen to bebelow 128° F. that in the end produces a result as measured in logsachieved for the inactivation of the targeted pathogen then is repeateduntil said logs achieved equate to those logs required for that targetedpathogen to be totally inactivated. That protocol creates what isdescribed to be a cyclical event stemming from the redundancy of theapplication of heat as the beginning point of pasteurization resultingfrom the internal heat of the subject chicken eggs achieving 128° F. andbeing elevated to the selected pasteurization temperature as measured byeach element within the chicken eggs each achieving temperatures whichat minimum are equal to or may slightly exceed the common internalpasteurization temperature targeted for each chicken egg. At the pointin time that all elements within the subject chicken eggs havingachieved the mentioned pasteurization temperature selected, the subjecteggs, depending upon their characteristics, are held at that temperaturefor a time which more or less achieves 1.0-logs at minimum. Postachievement of the mentioned log level resulting from the holding timeat the targeted pasteurization temperature, the subject eggs are cooledthrough preferably induced chilling to the extent that the outer albumensingularly reaches a temperature below 128° F. more rapidly through thepreferred induced chilling. Once that has been achieved the describedcycle is resumed and repeated until each element as previously describedto be within the subject chicken eggs has achieved the targeted loglevel which equates to the total inactivation of the targeted pathogenselected. The achievement of the log level targeted through the artemployed is enabled by the protection against heat damage of the outeralbumen which uniquely is accomplished through the intermittentprogrammed lowering of the temperature selected for pasteurization beingintermittently applied which includes the mentioned induced chillingalso being applied intermittently on a pre-programmed basis whichenables the outer albumen to fall below 128° F., as programmed to avoidheat damage. That protocol is unique within the art of pasteurizationand protects the outer albumen from heat damage while at the same timeallows for the denser portions of the subject eggs to continue toreceive heat albeit in lesser quantities, which, in the end, provideseach element including the outer albumen with a level of inactivation,which is complete, as applied to both bacteria and viruses that may bepresent while retaining substantially all of the physical andnutritional benefits of a raw egg.

The achievement of the targeted log level by each of the non-identicalelements of the subject in-shell chicken eggs is achieved by thecontinuous pasteurization provided to those elements, excepting that ofthe outer albumen for reason that, as mentioned earlier, the outeralbumen singularly is protected against heat damage causing loss of rawcharacteristics through programmed lowering and raising of itstemperature to below 128° F., which protects it against heat damage.Programmed test results confirm that the achievement of the targeted loglevel by the densest and most remote element within a chicken egg isfound to be the yolk. Through adjusting the holding time of the outeralbumen while below 128° F., damage to any one element within the egg interms of heat causing loss of raw characteristics is avoided by theautomatic reduction of the heat to each of the other elements althoughdiffering in their quantity and rate due to their differing densitiesand locations as related to both the outer albumen and the externalsource of the heat being transferred through the eggshell. Although thetargeted log reduction may vary between the least dense outer albumenwith those of the more dense other elements contained within the subjectin-shell chicken eggs, enough flexibility in heat tolerance has beenlearned to exist for those elements to allow for the targeted log levelof the densest element as found to be the yolk to achieve the sametargeted log level of inactivation, while at the same time avoidingdamage to the other elements i.e. the inner albumen and the vitellinemembrane without consequential loss of their raw characteristics. Thatcycle on average will produce a log result which as applied to eachelement of the chicken eggs will in non-exact form produce an expectedtotal single cyclical result of a 1.5-log reduction for each elementwithin the chicken eggs. Therefore, if the log reduction programmed istargeted to inactivate all strains of salmonella such would require upto eight cycles to achieve inactivation equating to 10-logs which in theend uniquely provides for the total inactivation of that pathogen. Asthe characteristics of the egg change and as the heat tolerance of thebacteria or viruses change so do the targeted log levels required fortheir inactivation, which is provided through the flexibility containedwithin the new art. This new art is adaptable to accommodatespecifically the peculiar and differing needs for inactivation of thetargeted pathogens through adjustments to separately or in combinationthe pasteurization temperature, the speed of each cycle and the durationof the time the subject eggs are held at the pasteurization temperaturealong with their time held at the lowest temperature which occurs whenthe outer albumen is below 128° F. The protocol employed is providedthrough a computerized program, which both computes and manages thespecific temperature settings and their durations to be employed alongwith the number of cycles required to achieve total inactivation of thetargeted pathogens without consequential damage to any one element ofthe subject chicken eggs. At the end of the cycles employed, thetargeted log reduction of the chicken eggs will have been achieved byeach of its elements but not in identical quantities. What will occur isthat each element having different density characteristics within theircomposition will reflect their differing tolerances to heat throughreceiving modest excesses to the logs provided within the formulaemployed to achieve the targeted log level of inactivation of thetargeted pathogens. Test results confirm that excesses to individualelements within the chicken egg are inconsequential to giving cause forloss of raw characteristics by any one element exceeding the targetedlog reduction from the particular formula variables employed under thespecifications contained within the new art. The results achievedprovide for total inactivation of the targeted pathogens, whetherbacterial or viral, as currently found or may come to be found within orupon chicken eggs, which no other art successfully has achieved througha production dedicated to commercial uses. That new achievement uniquelyis provided from the described cyclical application of heat and itsdenial which enables the total inactivation of targeted pathogensthrough achievement of required log levels performed in a manner whichprovides total safety to the consumer without damage to the rawcharacteristics of the subject eggs or the loss of their nutritionalbenefits. The two areas of primary inventiveness currently beingsummarized are described in greater detail earlier within this samesection. The same art provides for the elimination of the risk ofrecontamination of the subject chicken eggs from not only all salmonellastrains but also viruses which is enabled through the area of primaryinventiveness previously discussed and as is further discussed hereinbelow.

The benefits from levels of pasteurization described above, as madeavailable through the cyclical application of heat and its denial, hasbeen identified as the first of two primary areas of inventiveness,which now has been made available through the new art described andclaimed herein. That important area of new art is complemented by asecond primary area of inventiveness, which includes a new and uniquepasteurization medium that is secure from the risks contained within anexternal environment to which chicken eggs are exposed whether as rawin-shell eggs or as converted into pasteurized in-shell chicken eggs.The problems of initial contamination of chicken eggs, whether thecontamination is salmonella bacteria or viral, are not limited to cagedhens for reason that un-caged hens generally share the same exposures tocontaminants as caged hens which if not identical are replaced by thepeculiarities of sources unique to each environment.

Within the second element of the two primary areas of inventiveness, ascontained within the new art, the previously described new and uniquepasteurization medium provides total and continuous security from theexternal environment, which, in the end, enables the subject eggs to beprotected from the perils contained within the unprotected externalenvironment. In the unprotected external environment, the extremelydifficult problem exists, caused by airborne recontamination occurringeither post pasteurization or if not post pasteurization post lay whilethe internal eggs are contracting through cooling within a totallyunprotected environment until reaching ambient temperature. Certainattempts to sanitize rinse water applied to raw chicken eggshells havebeen utilized, but that practice is flawed to an extent from whichcontamination is enhanced and spread more often than reduced.

Exposures to the external environment post pasteurization under allprior art currently employed for in-shell egg pasteurization includesthe risk of airborne contaminants whose mass has been proven to beuncontrollable. That phenomenon gives cause for recontamination orincreased contamination to pasteurized eggs, resulting from the mass ofairborne salmonella cells created by the expansion of the subjectchicken eggs during pasteurization whose presence eliminates thebenefits gained from pasteurization by nullifying the safety levelsachieved through pasteurization. The problem described in substantialpart stems from the application of an antibacterial agent to theeggshells promptly after pasteurization. In this case, pasteurizationbecomes nullified by the speed of the airborne pathogens attachingthemselves to the exposed eggshells in great quantities within the timeframe of the three minutes provided from the time of exit of the eggsfrom the medium to the time of application of the antibacterial agent.Through the phenomenon described, the safety gained throughpasteurization is nullified. Pasteurization experience confirms thateven within an environment which employs a negative atmosphere to ridthe pasteurization area of airborne contaminants, the quantity ofairborne contaminants attracted to the exposed pores of the subjecteggshells in a matter of three minutes post pasteurization overcame boththe negative atmosphere of the pasteurization area and the protectivemeasures provided by the application of an antibacterial agent to alleggshells and their exposed pores, even when applied in drenchingquantities at a lower temperature than that of the internal eggs toensure their absorption. Such resulted in greater quantities of eggsbeing contaminated than would have existed had no pasteurization beenperformed.

All of the above issues are resolved by the second of the two primaryareas of inventiveness, which is referred to as the pasteurizationmedium. The pasteurization medium uniquely contains a securedenvironment, along with numerous safeguards contained within thatenvironment, to preserve its integrity, which includes total securityfrom the outside environment beginning at the commencement ofpasteurization through to its completion. The features of the new mediumcontaining the protected environment within which pasteurization isperformed are discussed in greater detail earlier within this samesection. The sealed environment of the medium avoids reliance upon anegative atmosphere, where pasteurization is performed as employed underprior art, which failed to provide protection and in fact allowed forrecontamination from airborne salmonella cells to occur in greatquantities all as previously described within this section. Atcompletion of the pasteurization performed under the new art but beforeexit from the medium, a protective sealant to the exposed eggshells isprovided to each egg. Unless damaged during shipment, the sealantprovides for the protection needed to maintain the subject chicken eggsto be both free from internal contamination and free from externalrecontamination, as a result of the combination of the eggs having beenpasteurized to be pathogen free to the levels required for such,together with the protection provided to prevent recontamination fromthe benefits of the environment within which pasteurization wasperformed, together with the protection provided against recontaminationthrough the proper sealing of the eggshells as described and while stillwithin the protected environment of the medium.

The first of two primary areas of inventiveness as is discussed andclaimed hereinabove at the inception of this section includes thecyclical application of heat and its denial to in-shell chicken eggs,which enables the unique ability to inactivate targeted pathogenswithout loss of the raw characteristics as found within raw in-shellchicken eggs.

The second primary area of inventiveness containing the vehicledescribed for pasteurization is identified and referred to as thepasteurization medium includes features enabling total inactivation ofpathogens which in turn enables the art contained within the previouslydiscussed first of the two primary claims contained herein to occur.Within the novel pasteurization medium its features include a new andunique self-sufficient and clinically safe environment for thepasteurization of in-shell chicken eggs from inception of pasteurizationthrough to its conclusion. The medium contains unique abilities toprovide purity to an end product through continuous purification of allelements within its secured environment. To perform the second of thetwo primary areas of the new inventiveness which includes the ability,more fully discussed hereinbefore, to pasteurize in-shell chicken eggsto materially higher logs than available under prior art as measured bylogs applicable to either or both viruses and salmonella bacteria. Inthe end, the medium provides for their total inactivation without risk,from commencement through completion, of the pasteurization protocolemployed to be subject to either recontamination or loss of thenutritional benefits and raw characteristics of the subject in-shellchicken eggs resulting from the pasteurization process. Such isaccomplished within the new medium which provides for the continuoussanitized protection of the equipment together with the continuoussanitization of the air contained within the secured environment of themedium, as well as the continuous sanitization of the water optionallyemployed in lieu of air to perform pasteurization. Collectively all ofthe above-described features contained within the medium provide for anenvironment which is supported by independent self-servicingcapabilities which enable uninterrupted pasteurization processing tooccur from commencement of pasteurization through to its conclusion. Thenew art also provides through its innovative improvements protectionagainst contamination from viral sources, whether internal to the eggbefore pasteurization or external to the egg post-pasteurization throughemployment of a protocol which enables total inactivation of all knowncontaminants to chicken eggs, whether viral or bacterial either existingor anticipated to occur. Such is accomplished through optional levels ofpasteurization made available under the new art which utilizes the newknowledge gained from the heat transfer rates of each of the differingelements found within a chicken egg, which is converted into a formulathat is applied through use of a repetitive protocol which enablesadjustments to achieve differing levels of inactivation as required fora specifically identified targeted pathogen or the strain of thatpathogen requiring a specific level of heat exposure for itsinactivation.

In summary, there are two new and unique primary areas of inventivenessfor pasteurization of in-shell chicken eggs, which when employedtogether in the manner described herein throughout enable theachievement of total inactivation of targeted pathogens which under allprior art never has been available without either damage to the rawcharacteristics of the subject eggs or the loss of their nutritionalqualities.

The first of those mentioned two primary areas of inventiveness involvesa programmed cyclical application of heat and its denial within whichadjustments are made to the application durations of the selectedtemperature of the heat being applied to the subject chicken eggshellstogether with its denial and its replacement with induced chilling forpre-selected application durations. Such is performed through programsemployed, which change from one to another as influenced by the targetedlog levels of inactivation required for a specific pathogen, as furtherinfluenced by the specific characteristics of the subject chicken eggs.Those targeted results include timings of the protocol employed, whichgovern the durations of the applications of heat and induced chillingwithout causing damage to the raw characteristics of the subject eggs.This ability is provided by the flexibilities of time and temperaturecontained within the protocol employed that enable the totalinactivation of targeted pathogens through the flexibility provided fromdiffering exposures to heat as tempered by the ingredients of the newart to be intermittent in its application of heat. a This allows fortotal inactivation of the most heat resistant pathogens which may befound or come to be found within chicken eggs.

In the preferred embodiment of the pasteurization medium described,which includes the protocol employed for heat gain and loss that targetdifferent elements within the composition of the egg, which through theselective management of heat, as applied to those elements, enables theacceptance of higher log levels of inactivation of both viral andbacterial contamination to occur without material reduction of the rawcharacteristics of the targeted chicken eggs. The cyclical applicationand denial of heat through induced chilling is accomplished throughmeasuring logs achieved, which result from heat application having beenapplied throughout the eggs in a manner which addresses the differinglocations and densities of each element within the composition of achicken egg. Those mentioned elements include the yolk, which is themost remote element of the egg and its equally dense vitelline membraneas well as the somewhat less dense inner albumen. Such is accomplishedby applying heat to the internal egg intermittently, whose limitationsare governed by the quantity of the heat applied to the whole egg asmodified and controlled from the higher rates of heat transfer as foundwithin the least dense element of the egg as represented by the outeralbumen. For ease of understanding, the lesser density of the outeralbumen requires only intermittent application or denial of heat toaccomplish targeted temperature changes. By using the outer albumen'shighest speed in heat gain or loss over those of the other elementscontained within chicken eggs that speed provides for the outer albumenachieving temperature changes together with targeted log achievementsmore swiftly than do other elements of the chicken egg. Through the useof intermittent but controlled durations of a unique method of theapplication of heat and denial of heat, the new protocol enablesapplications of heat in greater total quantities, which in turn enableshigher log reduction of targeted pathogens without damage to either theraw characteristics of the chicken eggs or a reduction in theirnutritional values. At the same time, the new protocol provides totalinactivation never before achieved of viruses and bacteria requiring upto or exceeding 12-logs, as measured by Se, which under current scienceenables inactivation of all strains of either viruses or salmonellabacteria as currently found or likely to become found within chickeneggs.

When performed by one reasonably skilled in the art, the monitoring ofthe denser vitelline membrane and yolk together with environmentalfactors which influence pasteurization in general, from impact by suchextraneous factors including but not limited to altitude, egg watercontent and egg size along with the targeted pathogens to beinactivated, produce results which can be factored into an equationemploying intermittent applications of heat to the subject eggs in amanner previously referred to as the cyclical application of heat andits denial. Whether pasteurization is performed through a formulaemploying either purified air or purified water, adjustments to theformula in relation to time and temperature will be required, as appliedto their respective rates of flow. These rates of flow will be adjustedto accommodate not only the rates of flow of both water or air, asemployed to accommodate their individual densities which impact upontheir rates and quantities of heat or chilling transfer due to theirdiffering compositions both separately and comparatively, together withtheir end impacts upon the rates of heat or chilling transfers due todiffering in-shell egg sizes, which in the end collectively enable thespecific characteristics of the batch of in-shell chicken eggs beingprocessed to achieve total inactivation of targeted pathogens withoutinconsistencies of consequence to the end product. In the end, thetargeted and never before achieved log levels enabling the destructionor inactivation of both salmonella and the more heat-resistant strainsof viruses now threatening to cause a pandemic can be totallyinactivated without consequential loss of raw egg characteristics by thetargeted chicken eggs due to their varying sizes and differing rates ofheat and chilling transfer.

The second of the above mentioned two primary areas of inventivenessinvolves the employment of the pasteurization protocol within aprotected environment provided by the pasteurization medium, whosebenefits provide security from risks of either incomplete inactivationof pathogens or recontamination which when achieved together providescertainty that no statistical risk of illness of consequence from eitherviral or bacterial contaminants as found or may come to be found withinchicken eggs will occur.

As a result of the two above described areas of primary inventiveness,consisting of the cyclical application of heat and the medium withinwhich it is employed, when employed in tandem such provides the publicwith the benefits from not only the newfound safety from illnessestraditionally caused by eggs which are reported to be the leading causeof foodborne illnesses but also provides the public with the benefitsfrom the subject eggs retaining nutritional, functional and aestheticcharacteristics as found within their pre-pasteurization raw states.Further, the new art not only accomplishes the achievement of theretention of raw egg aesthetics and nutritional featurespost-pasteurization through employing ingredients of the new artclaimed, which includes the use of fluctuating temperatures as appliedto the internal ingredients of the subject eggs as is made availablethrough the intermittent and alternating applications of both heat andinduced chilling together with the timing of programmed applications anddenials as described in greater detail herein before. Said new art alsoenables the statistical inactivation not only of all deviations of allstrains of salmonella, as found within chicken eggs, but also enablesthrough its unique ability to provide flexibility to the levels of heatexposures and cooling exposures to provide for the benefits to be gainedfrom total destruction of viruses which require materially greaterlevels of heat for their destruction than do the most heat-resilientstains of salmonella bacteria. Further, the new art in the second of itstwo parts, as described earlier, provides for a unique pasteurizationmedium within which the environment is secured from externalcontamination. Such enables prevention from recontamination and to allowfor the total inactivation of pathogens as found within chicken eggs tooccur. Those critical benefits are enabled through the flexibility ofthe cyclical pasteurization protocol employed together with the benefitsprovided from the achievement of log levels required for theinactivation of the targeted pathogens to be complete and without riskof either residual contaminants being present or inadequatepasteurization to have occurred.

Notably and of significant distinguishing importance over prior art, thenew art not only provides for satisfaction of deficiencies to currentpasteurization protocols employed, as found within both in-shell chickeneggs and liquid whole egg product, which as acknowledged throughGovernment agency reports, together with interpretations of studiesperformed by the scientific community, confirm that a 5-log protocol forSalmonella inactivation limited to Se is inadequate to provide publichealth protection against known to be highly salmonella contaminatedchicken eggs giving cause to illnesses whether from in-shell chickeneggs or from their conversion into liquid product forms. A moreappropriate log reduction of all strains of salmonella, when consideredtogether, is confirmed through science to be 10-logs to achievesalmonella inactivation. Some would argue that a 5-log level ofinactivation of salmonella as identified to be Se would inactivatereasonable deviations in levels of contamination as found within acontaminated chicken egg for a period of time post lay, which would notnegatively impact upon public health. That argument would be furtheredby reliance upon deep chilling occurring from time of lay through timeof consumption. Unfortunately, the reality of promptly achieving andmaintaining deep chilling without interruption from farm-to-table as ispracticed in the United States and within selected other countries isdangerous to rely upon to avoid the speed within which salmonellamultiplies into both sickening or lethal quantities. As one example, onecell in one egg in a non-refrigerated but normal room temperatureenvironment within forty days of lay may achieve a cell count of onetrillion cells. At that level which approximates the same timeframe asthe date of lay together with the timeframe to packaging and the ‘BestBy’ date displayed on egg cartons combined with the risk from salmonellafood poisoning to the public at large is significant. Such is enhancedby interrupted refrigeration from farm to table, the known andauthorized inclusion of substandard eggs containing high levels ofsalmonella contamination into liquid egg product employing an equallysubstandard level of pasteurization of 5-logs as measured by Se, theco-mingling of Grade B eggs into Grade A cartons, the repackaging ofstale eggs into new cartons containing new ‘Best By’ dates whenconsidered together create in part the reason why chicken eggs whetherpasteurized or not remain to be the leading cause of foodborne illnessin the United States. Such result is furthered by the vulnerability ofsome 150.0 million persons identified by the Government as being membersof high risk groups which on average consume a minimum of 15 dozenchicken eggs annually. As discussed herein elsewhere, eggs known-to-behighly contaminated are allowed to be contained within co-mingled liquidegg product as one illustration of reckless oversight. That enablementis provided under the Egg Safety Rule of 2009 as sponsored by theUS-FDA. Eggs identified to be of Grade B standard are allowed to beco-mingled with Grade A labeling. Eggs provided to food service do notemploy ‘Best By’ dates. Those recited common practices are only a few ofseveral which together in part provides an answer to why chicken eggsconsistently for decades have been the annual single most source of foodborne illnesses.

In the instance of new strains of viruses, such carry with them a newand unique public threat not previously experienced from chicken eggs asis found under the H5N1 virus with its potential ability to transferserious and frequent fatal illnesses from human-to-human or at the leastgive cause to serious illnesses through consumption of eggs containingthe H5N1. Those underlying issues have given cause for the scientificcommunity to forecast that the H5N1 through continuing mutations ordeviations is a strain of virus which is most likely to give cause foreither one of or part of a base viral source to convert into anaggressive viral source which in the end creates the already confirmedarrival of that virus together with potential deviations creating afoundation for millions of illnesses stemming from less than hard-cookedchicken eggs even without its potential furtherance for human to humantransfer. The described deficiencies of current chicken eggpasteurization protocols to successfully inactivate salmonella astargeted by Se at a 5-log level of inactivation combined with thegreater levels of inactivation over salmonella required to inactivateviral contaminations, when considered together, reconfirm the warningsprovided by WHO. These warning indicate that the public at large isexposed to illness from Avian Influenza and the forecasted pandemicresulting from both the virus continuing to evolve and the vaccinedevelopment being incomplete due to the continuous evolution of thevirus giving cause to what essentially can be described as a movingtarget. The new art disclosed and discussed herein provides for a uniqueprotocol to be employed to eliminate the threat to public health, ascurrently found to stem from salmonella primarily but also as alreadyforecasted by the international scientific community, which continues toreport that a new and participating source contributing to the magnitudeof a potential pandemic has been confirmed to stem from Avian Influenzaas enabled through the more heat-resistant viruses now identified to becarried by chickens as illustrated primarily by the H5N1 virus nowpresent and continuing to evolve. Viruses together with their deviationsmay come to provide for human-to-human transfer of illnesses. Virusesare heat-sensitive but require greater heat than all prior chicken eggpasteurization art can deliver to achieve total inactivation of viruses,as well as all strains and levels of contamination of chicken eggs bysalmonella without loss of raw egg characteristics. The new art claimedherein discloses pasteurization to be available against bothavian-caused influenza and salmonella-caused illnesses while at the sametime retaining the raw characteristics of a chicken egg together withenabling those same eggs to provide a safe food source to a public inneed of such. The mentioned new art performs pasteurization preferablythrough substitution of a treated water bath with a spray of eithertreated air or treated water at varying densities and velocities withina secured environment.

The new art discussed above enables public protection which is timely.The discussed virus strains which in part will be found within chickensand their eggs as deviations from strains already existing will in theend contribute to a global pandemic in a magnitude comparable to that ofthe 1918 pandemic as has been reconfirmed by current forecast providedby the World Health Origination. That pandemic killed well in excess of75 million people. In support of an increase in numbers of causalitiesresulting from a new pandemic over the casualties estimated as havingoccurred in the mentioned 1918 pandemic such is influenced by bothpopulation growth and ease of spread through current public mobilityover that of the 1918 timeframe.

Notably and significantly, reports from mid-2015 and prior as authoredby the scientific community including WHO discuss the need fordevelopment of a vaccine together with the delays occurring for thatdevelopment as being caused primarily from the continuing evolution ofthe virus which may enable not only Avian Influenza to occur but also inmaterial part will create massive contamination to chicken eggs thatmaterially will broaden the scope of the pandemic.

As previously discussed, the threat of a pandemic generated by a virusrepeatedly is forecasted by the scientific community as being both inthe making and inevitable. Potential evidence of the accuracy of thatforecast occurred in the United States in 2009-2010 which was reportedpublicly a year later in 2011. A new strain of virus having certainsimilarities to prior viruses identified as a category to be within theSwine Flu species occurred in the United States only with notable lackof publicity as to its scope and devastation. The strain of virus wasnew but resembled characteristics of those found within the Swine Fluwhich is not limited to swine. Confirmed reports show that within theUnites States in less than a two-year span i.e. twelve months bridgingtwo years more than 60 million people were sickened and 12,000 personsdied. The virus was identified as the H1N1.

Recent scientific studies confirm that a 5-log pasteurization protocolfor salmonella more specifically identified as Se as found withinchicken eggs is inadequate to inactivate all strains of salmonella ascommonly found within chicken eggs. Such inadequacy is confirmed by ahost of public health agencies all of which also confirm thatsalmonella-contaminated chicken eggs gives cause to public illnesses ingreater quantities than found to be within any other food group. Such isconfirmed by reports from both the USDA Office of Inspector General andfrom reports from the National Egg Regulatory Officials. Anecdotally butpertinent to reports which in the end impact upon health risks to thepublic, the selected use of Se as the functioning strain of salmonellaas found within chicken eggs was selected primarily because of itsbelieved and somewhat assumed prevalence to be within but not upon thechicken eggs at time of lay resulting from contamination of the ovariesof the laying hens providing for a long-standing estimate of a frequencyof 1 egg in 20,000 eggs being contaminated from Se whose locationprimarily is reported to be within the ovaries of the laying hens.Significantly, little attention has been paid to the long-standingacknowledgment that the H3N1 virus has been found to be present withinchicken flocks for decades. In the case of Se when present within layingflocks the subject flocks must be destroyed and their eggs must beeither destroyed or pasteurized to the then level of 4-logs or the morecurrent level of 5-logs as measured by Se. The same protocoltraditionally has been employed by the USDA and the US-FDA pertaining tochicken flocks producing eggs containing the H3N1 virus for decades. Thenew art claimed herein inactivates viral contamination of chicken eggs,which require higher levels of inactivation than do those bacterialstrains as found within chicken eggs. Notably, for decades prior to 2009the US-FDA and other agencies of jurisdiction or of interest allowedH3N1-contaminated eggs as well as salmonella-contaminated eggs to beco-mingled or separately converted into liquid egg product and to beprovided to the public in liquid egg form while employing a level ofpasteurization of 4 logs as specifically measured by Se without regardto higher inactivation levels required by viruses or other more heatresistant strains of salmonella than Se. Further, it was known all alongthat a 5-log level of inactivation of Se was inadequate to inactivatesalmonella at levels known to be frequently achieved within contaminatedchicken eggs employed within and subjected to a 4-log pasteurization ofliquid egg product which when changed to 5-logs then included in-shellchicken eggs. Further to the above the 5-log level of inactivation wasreconfirmed through the US-FDA sponsored Egg Safety Rule of 2009 whichfinally omitted references to the H3N1 virus but continued to employ a5-log inactivation level for all strains of salmonella bacteria whennumerous specific violations of eggs allowed to be employed forpasteurization had no hope whatsoever of being safe for publicconsumption unless hard-cooked. Details of those violations already havebeen stated within this section hereinabove.

Significantly and notably, as a separate area of public misinformationto that of the above-mentioned H3N1 virus being inactivated at 5 logs asimilar misrepresentation of reliance upon a 5-log level of inactivationfor all salmonella strains also has existed. Those dualmisrepresentations have been conveyed to the public as providing eggssafe for consumption within all recipes containing chicken eggs ifpasteurized to the mentioned 5-log level of Se when none such safetyexists. What now seems obvious is that all chickens are exposed to henmanure as well as rodent manure within their feed prior to the eggsbeing laid. The internal contraction of the eggs post lay draws inexternal contaminants which may be either airborne as within a henhouse, contact with manure from the hen itself or contact withcontaminated air carrying salmonella bacteria of multiple strains whichwould include but not be limited to Se. Since common practice within theUnited States employs rinse water to cleanse the eggshells from manurethat protocol carries with it the risk of spreading contaminationlocated on the eggshells practically post loss of the natural protectivesealant either from the passage of a few days in time or from the rinsewater employed that usually is unclean. Hence, no egg in currentcirculation can be assured to be safe.

All of the above described issues which have been practiced for decadesnow can be overcome through the benefits provided from the new artclaimed herein which achieves total inactivation of both bacterial andviral contamination as may be present within eggs which may beco-mingled with eggs that have escaped contamination. Such provides aremedy to the lack of notice by agencies of jurisdiction to the simple,obvious and logical fact that at time of lay the subject chicken eggsmay be internally warmer than the hen house environment which would givecause for the eggs to contract internally and to draw in contaminatedmoisture being applied to the eggshells or air which too is likely to becontaminated. The problems of contamination of the eggs throughcontraction as discussed are similar to the issues experienced by priorart employing pasteurization which gave cause to massive quantities ofairborne contamination to occur during a brief period made availablefrom the timeframe of the eggs exiting the pasteurization medium throughto the time of application of an antibacterial agent being applied tothe exposed pores of the subject eggshells which occurred in a matter ofapproximately three minutes even when countermeasures of an increasednegative atmosphere within the pasteurization setting was employed. Thenew solution contained herein to provide certainty of safety whilepreserving the nutritional and natural taste of the subject eggs ispasteurization to a log level which provides the needed certainty ofinactivation of all pathogens threatening public safety as performedwithin a medium that provides the subject eggs with protection againstrecontamination from point of entrance into the medium through to thepoint of exit from the medium post pasteurization through toconsumption. That art now becomes available through the claims recitedherein.

Of notable significance to the new level of safety benefits uniquelyprovided under the new art discussed and claimed herein in significantcontradiction to the new discoveries the US-FDA as recently as in 2009not only confirmed under The Egg Safety Final Rule that co-mingled andso-labeled highly contaminated chicken eggs could be utilized for publicconsumption without restriction of any nature if pasteurized to a 5-loglevel of inactivation of Se. Notably, the end product bearing the term‘PASTEURIZED’ and not bearing the contents of the ‘Safe HandlingInstructions’ required on raw egg cartons is misleading although itcontinues to be employed. It is general knowledge that a 5-loginactivation of Se whether for in-shell chicken eggs or withinco-mingled liquid egg product under current practices already describedhas no hope whatsoever of providing reliable safety to replace the needfor hard-cooking. The misinformation provided to the public isparticularly more noteworthy for the 150.0 million persons containedwithin risk groups. Material to the risks and inadequacies of thecurrent pasteurization process enabled under the mentioned Rule theinclusion of known to be highly contaminated chicken eggs containinghigh counts of salmonella already present is allowed. Those alreadyhighly contaminated chicken eggs in part result from insufficient orinterrupted cold storage, repackaging of unsold product bearing new andmore current dates and distribution practices enabling temperaturechanges which enable inordinate multiplication of salmonella to bepresent at time of public consumption as either in-shell eggs orconverted into pasteurized liquid egg product even when the subject eggshaving been exposed to an environment pre-pasteurization enablingsalmonella multiplication prior to processing to achieve frequent countlevels reaching one billion cells or more even prior to processing andpackaging of the subject eggs or converting a pre-dedicated portion ofsaid eggs into liquid egg product pasteurized to a 5-log level of Seinactivation. The levels of contamination described in the end wouldrequire a level of pasteurization of Se as measured in logs equating toa minimum of 10 logs in lieu of the described US-FDA requirement of 5logs as measured by Se to qualify the subject eggs to be labeled as‘PASTEURIZED’ and to be represented to the public as safe forconsumption when less than hard-cooked.

Thus, under prior art the mentioned inactivated contaminantspost-pasteurization to the 5-log level of Se inactivation were enabledto rapidly multiply in the absence of immediate and continuous inducedchilling whose purpose only is to retard the mentioned multiplicationthat in practice neither inactivates nor destroys the targeted virusesor bacteria. Even were the minimizing of the multiplication rate throughprompt chilling to occur the time lag to deep chill stacked eggsprovides adequate time for higher levels of pre-contamination to becomepotentially lethal to high risk groups even were the eggs to achieveuninterrupted deep chilling from the initial application of the chillingthrough to table. In support of the unreliability of continuous anduninterrupted deep chilling from farm to table the national distributionsystem for chicken eggs when considered together with interruptedtransportation and storage caused by time and distance together withbreakdowns and delays from weather conditions collectively contribute toa level of risk of illness not utilized as part of the protocol forsafety provided from continuous and prompt deep chilling as performed ina laboratory setting.

The above-described circumstances outline the public health risks causedby the inordinate speed of multiplication by pathogens includingsalmonella with the resulting achievement of becoming lethal throughtheir increased count in a matter of days only. Certain Governmentagencies have reported that immediate and continuous deep chilling fromfarm to table will avoid multiplication of salmonella into lethalquantities. That described protocol employing refrigeration isdisqualified on its face. It is impossible to perform with reliableconsistency deep and uninterrupted refrigeration from farm to table asrequired under a Hazard Analysis Critical Control Point's (HACCP) planrelying upon the described deep refrigeration when nonesuch is feasibleor reliable in practice from date of lay through date of consumption.That reliance is known to be false but continues to be allowed throughthe mislabeling of product which provides for misplaced productconfidence at the expense of at minimum 150.0 million persons within theUnited States identified as having compromised immune systems who haverelied upon the implied safety provided by the term ‘PASTEURIZED’ asfound upon liquid egg product cartons and the USDA Shield as providedupon raw in-shell chicken egg cartons which on their face providesimplied safety from bad food while at the same time the same agencies ofjurisdiction have known full well that chicken eggs rank as the leadingcause of illnesses annually over all food groups. That long-lastingstatistic considered together with the obviousness that a 5-log level ofpasteurization of already highly contaminated chicken eggs co-mingled asallowed with lesser contaminated eggs but labeled to be Grade AA andGrade A or allowed to be repackaged into new cartons containing newdates which are untrue in combination give cause to a public health costfrom chicken eggs which when resolved through pasteurization achievingsafe levels would provide for a public savings in costs of illnessesequating to the national debt each year i.e. $20.0 trillion annually.

Notably, the arrival of viral contamination within chicken eggs, atbest, has been rare and when previously mentioned has been limited tothe H3N1 virus. In those references to the H3N1 virus the same level ofdestruction or inactivation was employed through pasteurization ofliquid egg product equating to 4 logs using Se (bacteria) as thebaseline of measure until 2009 when the level of inactivation was raisedto 5 logs as applied to Se. It is obvious to the scientific communitythat the inactivation of a virus requires either greater heat asmeasured in temperature or longer terms of heat at lower temperaturesthan does salmonella. The H3N1 virus for decades erroneously was treatedas having the same heat tolerance as Se which in turn was not the mostheat-resistant salmonella strain found within chicken eggs. The reportederror regarding the H3N1 virus and the inadequacies concerning loglevels for its inactivation clearly have placed the public health atrisk. To compound the problem recited disagreements on inactivationrequirements through pasteurization between agencies of jurisdictionhave occurred resulting from misinformation concerning risks anddiffering information concerning the avoidance of risks. No studysupports the long-standing position by agencies of authority that thevirus identified as the H3N1 was inactivated at the same level as a5-log inactivation employing Se as the measure when in fact viruses longsince have been known to require the earlier-reported ratio which in theend confirms that the H3N1 inactivation of 5 logs required an Seinactivation of 6- to 7-logs. That error has exposed millions of theegg-consuming public to risks of illness from the H3N1 virus that priorto pasteurization of in-shell chicken eggs had no protective measurewhatsoever for the consuming public.

In 2014 WHO continued to acknowledge that a pandemic generated from anAvian Influenza viral source since referred to as the Bird Flu was inthe making. The only question left open was when such would occur andnot whether such would occur.

Notably to the above-referenced forecast by WHO that the contaminationof chicken meat by two new virus strains has been reported by a leadingUnited States supplier on two occasions in October of 2013. The pressreleases disclosed that Tyson Foods, one of the nation's largest chickenmeat providers, had destroyed flocks containing the H7N7 virus. Thosereports confirmed the very recent arrival of the virus into the chickenfood chain. It also confirmed that the same virus only recently hadtraveled from Asia to the United States. Logic dictates thatcontaminated chicken eggs and the pandemic as recently forecasted by WHOand referenced as the ‘Bird Flu’ may be only one mutation away fromoccurring. Such is confirmed through prior statements discussedhereinabove which report that the U.S. agency identified as the HHS hascontracted with a French-based firm to develop a vaccine in anticipationof the so-called ‘Bird Flu’. The contract size involves $150 million forthe research and development program.

The new art described and claimed herein for chicken egg pasteurizationprotocol uniquely provides for a secured environment which hereinbeforehas been referred to as the medium. The medium prevents recontaminationto which all prior art concerning in-shell chicken egg pasteurizationfailed to accomplish. Under certain protocols contained within prior artthe in-shell eggs exited the pasteurization medium and promptly beganinternal contraction during ambient cooling. Between the time of exitfrom the prior pasteurization mediums employed to the time that anantibacterial agent was applied to the exposed eggshellspost-pasteurization as followed by an insufficient coverage of theeggshell provided by a protective sealant as performed under prior art,the eggs experienced not only recontamination but greater quantities ofeggs became contaminated as a result of the process both beingincomplete in its level of inactivation of salmonella but also throughdeficiencies of the protocol employed being absent of protection againstairborne recontamination. The mentioned airborne recontaminationresulted from the inordinate quantity of shell eggs being pasteurizedconcurrently and effectively exhaling through the shell pores thecontamination contained within each contaminated chicken egg. When thesubject eggs had been pasteurized to the targeted log level and wereexited from the medium i.e. water bath the subject eggs begancontracting. That created an air current caused by the en massecontractions which overcame the negative atmosphere provided for thepasteurization facility. The result made inapplicable the long-standingstatistic that only 1 egg in an estimated 20,000 eggs wasSe-contaminated by infected ovaries prior to pasteurization, but alleggs post-pasteurization were placed at risk of airborne salmonellacontamination relocating on each eggshell for reason that the currentcreated by the mass of eggs contracting overcame the negative atmosphereof the room within which the pasteurization occurred. Such not onlynullified the benefits of pasteurization but also increased the quantityof eggs contaminated.

The new art contains protocol which not only solves the above-recitedissues of inadequate pasteurization and recontamination as applied tosalmonella presence within pasteurized in-shell chicken eggs, but alsoprovides protection against both the more dangerous and virulentinfluenza strains as well as inactivating salmonella at log levelsgreater than 5 as measured by Se to that of 10 logs, which conforms withthe original levels of inactivation of Se for liquid egg product as setby the USDA originally. Further to the above, the new protocol achievesinactivation of viruses, which equates to an additional 1.5 to 2 logsover that which inactivates salmonella in strains, which have highertolerance to heat than does Se also as confirmed by USDA scientists.Such is enabled by the cyclical application of heat and its denial asdescribed in greater detail hereinbefore. With reference to what hasbeen stated before, which more briefly described is that an importantand new feature of the new art claimed herein enables for the first timeegg pasteurization to achieve total inactivation of all salmonellastrains, as well as strains of influenza expected to arrive and tocontaminate chicken eggs are enabled through the achievement of loglevels which limited all prior art to levels of achievement which wereinadequate to provide total inactivation without damage to the rawcharacteristics and nutritional benefits of the subject eggs. Theinadequacy essentially was covered up to the public by allowing a 5-loglevel of inactivation to be endorsed as being effective in theelimination of salmonella from chicken eggs which was known or shouldhave been known to be not only false but dangerous to the consumingpublic. In principle and in practice the cyclical feature of employingheat and its denial as detailed elsewhere herein as being a feature ofthe new art described and claimed is expandable for higher log levelachievements or may be employed for inactivation solely of salmonella asthe situation present may warrant which in all cases can be performed tonot only provide for total inactivation of the targeted pathogen butalso enables the retention of both nutritional and raw characteristics.

In conclusion, when the described new art of pasteurization is performedand has achieved total inactivation of pathogens without negating rawegg characteristics, as enabled through utilizing the new protocols madeavailable and performed within the described environmentally-safemedium, the successful achievements of an end product will consist ofpasteurized eggs statistically free of both viral and bacterialcontaminants while at the same time preserving the nutritional,aesthetic and functional qualities of a raw chicken egg. No prior artfor chicken egg pasteurization has met those standards on a commercialscale.

Notably the described features under the new art as recited whenperformed together enable higher and needed levels of pasteurization tobe available for the total inactivation of pathogens, which include butare not limited to viral contaminants and salmonella bacteria as may befound to be present or forecasted to become found within chicken eggs.That described total inactivation results from new discoveries whichenable the elimination of either or both underpasteurization orrecontamination, as found within current pasteurization protocolswhether for in-shell chicken eggs or liquid egg products. Such isaccomplished through the uniquely interrupted application of heat andthe equally unique interruptions of induced chilling both of which areperformed within a novel pasteurization medium, whose uniquespecifications contain features which enable the described secured andsanitary environment for pasteurization. The combined benefits madeavailable through the features of the areas of new inventiveness, eachof which contain elements that are unique unto themselves, provide for astatistical certainty of safety to the public from the consumption ofcontaminated chicken eggs. Such contaminated eggs currently causesalmonella food poisoning together with similar safety from new threatsto public health caused by viral contamination whose potential forlethal illnesses resulting from its evolution and greater resistance toheat inactivation already has been confirmed by the scientific communityat large. The described threats from either or both viruses andsalmonella, whether in combination or separately, provide for largequantities of illnesses which in the end support the forecast of apandemic occurring. Unlike prior pasteurization protocols, which placethe public health at risk, the new art includes the benefit of certaintyagainst contamination or recontamination of chicken eggs as provided bythe secured medium within which the new art enabling total inactivationof targeted pathogens is performed absent of risk or compromise to thepurity achieved. Such is enabled by both the safe environment of thementioned medium and the log levels of inactivation achieved for thetargeted pathogens while maintaining the nutritional and functionalqualities of a raw chicken egg whether its end use is for in-shellrecipes or versions of liquid egg product. The collective art in itspreferred form as employed is unique from all known prior protocol andtheir specifications.

The protocol claimed and described herein provides for options whichinclude but are not limited to in the first instance an option which isnot the preferred option that consists of one tank containing afood-grade sanitizer within water which in its utilization provides forrinsing and sanitizing in-shell eggs prior to entering the securedenvironment of the pasteurization medium. A second option is to replacethe external tank containing treated water with an external shower alsocontaining a food-grade antibacterial agent, which performs the samefunction as described for the first option employing a bath but providesfor the application of a heated spray of water containing anantibacterial agent to pre-sanitize the eggshells prior to theirtransfer from the external application of the mentioned shower into thepasteurization medium. That described spray of water employed prior tothe subject eggs being transferred from outside the pasteurizationmedium into a location within the pasteurization medium is the preferredprotocol to be employed. That protocol employing prescribed andsanitized heated water in the form of a spray outside of thepasteurization medium may be substituted with an application of purifiedair which has been found to be of equal effectiveness to a spray ofwater when modified accordingly. The employment of the mentioned sprayof purified air in lieu of purified water both employing food-gradeadditives would satisfy jurisdictions restricting the use of water beingapplied to eggshells in their raw state. Under all circumstances thesubject eggs upon entry into the secured environment of thepasteurization medium will receive a spray of sanitized water to provideadditional cleansing of the eggshells, as enabled by the sanitized waterbeing heated to a temperature higher than the subject in-shell chickeneggs but below 128 F. which is the temperature recognized to representcommencement of pasteurization. The shower employed may include in itscomposition either purified water or purified air at controlledtemperatures which are preprogrammed to accommodate the specificcharacteristics of the subject chicken eggs being processed through anautomated program adjusted accordingly.

Post receipt of the above-described treatment of the eggs to protectagainst external and perimeter invasion of pathogens gaining accessthrough potentially exposed eggshell pores together with those pathogenswhich may be located between the shells and the eggs' outer membranes,the subject eggs upon entry into the pasteurization medium are subjectedto an increase of temperature to achieve the preferred initial internaltargeted temperature for pasteurization of 132.5° F., which may beadjusted to reflect the needs peculiar to the raw chicken eggs selectedas more fully discussed herein before. That targeted temperature is apreferred temperature that also is subject to adjustment based upon aseries of factors concerning variances within eggs or the environmentwithin which pasteurization is employed as has been more fully discussedhereinbefore. For better understanding the protocols for the employmentof new inventiveness enabling the statistically complete inactivation ofmore aggressive and heat-resistant viral pathogens over those ofsalmonella bacteria is a unique feature of the new art which providesfor a selection of options discussed hereinbefore from which theprocessor selects.

Once the subject eggs have been transferred within their customizedstacked flats post having received the preferred external rinsecontaining heated water treated with a food-grade antibacterial agentand having been transferred into the protected environment of thepasteurization medium the pasteurization protocol can be commencedwithin the secured environment of the medium which contains continuousprotocol for maintaining the purity of that environment as discussed inthis section previously. The pasteurization protocol employed as alsodiscussed within this section earlier provides for applications of heatand its denial which in the end through adjustments automaticallyprogrammed enables the total inactivation of targeted pathogens throughthe described intermittent application of heat, its denial and theintermittent application of induced chilling which in practice isperformed redundantly until the targeted pathogen statistically has beeninactivated but in a manner which preserves its raw aestheticappearance, its nutritional benefits and its functional characteristicsas likened to those of a raw in-shell chicken egg.

While the foregoing disclosure shows illustrative embodiments of theinvention, it should be noted that various changes and modificationscould be made herein without departing from the scope of the inventionas defined by the appended claims. The functions, steps and/or actionsof the method claims in accordance with the embodiments of the inventiondescribed herein need not be performed in any particular order.Furthermore, although elements of the invention may be described orclaimed in the singular, the plural is contemplated unless limitation tothe singular is explicitly stated.

1. A method of pasteurizing in-shell chicken eggs which achieves totalinactivation of targeted pathogens comprising of: (1) pasteurization ofthe subject eggs is preceded by placing the in-shell chicken eggs intocustomized flats whose design maximizes the exposure of the eggshells tothe temperatures of the fluids employed to provide for a level ofexposure of the subject eggshells equating to 95%; and (2) allowing theeggshells of the subject eggs to be exposed to a preheated fluid whosetemperature will be selected from a preferred range of temperatures ofand between 128° F. and 138.5° F. to perform pasteurization; (3) thepreferred fluids employed for pasteurization are either in a liquid formas found within water or in a gaseous liquid form as found within air;(4) a food-grade approved anti-bactericide will be employed within thepasteurization process to add certainty to the otherwise employedprotocols performed which include the uses of anti-bacterial fluidsapplied to the eggshells while concurrently receiving exposures from alight beam as found within ultraviolet which in each case perform asadditives to treated water or as additives to treated air which in allsubstances selected will be compatible to its co-mingling with air thatin all options benefit from the presence of applied heat as well asapplied chilling as employed within water when used as thepasteurization transfer vehicle or within air as an alternate fluid tothat of water when employed as the pasteurization transfer vehicle; (5)the food-grade agent to be employed within the selected fluid whethersuch fluid is water based or air based will include the selection of abactericide with capabilities to function at temperatures which rangefrom approximately 120° F. to 150° F. to cover the temperature rangespectrum of the new art employed which allows for overshooting thepreferred pasteurization temperature selected to allow for improvedproduct quality controls derived from said overshooting; (6) post theinitiation of pasteurization and equilibrium between all of the separateelements within the subject chicken eggs having been achieved with thatof the selected pasteurization temperature the subject eggs are allowedto dwell at that selected pasteurization temperature for a prescribedtime which equates to the time required to achieve a 1.0 to a 1.75 logreduction of the targeted pathogens; and (7) discontinuing theapplication of a heated fluid and replacing the heated fluid with afluid containing a temperature below 128° F. which for both consistencyand efficiency purposes will be served by a separate line carryingseparate nozzles and fluid including air as an option constantlycirculating and chilled to a predetermined temperature and allowing thesubject eggs to dwell at the temperature selected below 128° F. untilsuch time as the outer albumen achieves a temperature below 128° F.; and(8) upon the outer albumen reaching a temperature below 128° F. thesubject eggs continue to be exposed to the temperature of the chilledfluid for a period of time ending with the inner albumen achieving atemperature of 128° F. or slightly higher i.e. 129° F. more or less; (9)once the inner albumen has achieved a temperature between 128° F. and129° F. the chilled fluid is discontinued and replaced with the heatedfluid whose temperature as recited is selected from a range oftemperatures between 128° F. and 138.5° F. Once the internal eggtemperatures have reached equilibrium with the selected pasteurizationtemperature the completion of a pasteurization cycle has been achieved;and (10) the logs achieved from each cycle will include log levelsachieved from come-up times and come-down times cumulatively; (11) thecycles are replicated until the total inactivation of the targetedpathogen has been achieved; (12) upon achievement of total inactivationof the targeted pathogens having occurred the subject eggs while in theprotection of the isolated and sealed environment are allowed to cool.That cooling gives cause to internal contraction of the subject eggs.Such provides an opportunity to directly apply any one of US-FDA FoodUse approved bactericides which contain shelf life time sufficient toallow for the application to the exposed eggshell pores and to allowthat bactericide to spread throughout the internal contents of thesubject eggs between its membrane and its shell to further ensure theinactivation of stray pathogenic survivors; the (13) above protocol isfollowed by the application of a food-grade wax or a food-grade plasticsealant to the exposed eggshell pores while the residual heat within thesubject eggs is causing contraction of the internal egg. Thatcontraction provides an opportunity to draw the sealant inward whichcreates a seal to the pores of the eggshells and provides protectionagainst recontamination post exit from the medium; (14) the recitationscontained hereinbefore represent the novel features of a sequentialprotocol to be employed for achieving total inactivation of targetedpathogens as may be found within in-shell chicken eggs which is achievedthrough providing prescribed and intermittent applications of heat andchilling which is performed according to the tolerance levels to heatfound to be present within the outer albumen of a chicken egg; (15) theachievement of inactivation of targeted pathogens under the new artdescribed hereinabove initially targets a 10.0-log level of inactivationof viruses anticipated to be potentially a co-contaminate of in-shellchicken eggs which correspondingly according to current science equatesto a 12-log inactivation of the most heat resistant strains ofsalmonella bacteria as could be commonly present within chicken eggs;(16) were the targeted pathogens to alter their nature or resilience toheat to require still higher log levels of inactivation greater than thenew art claimed herein anticipates the new art accommodates thosepotential needs for still greater levels of inactivation through simpleadjustments to the protocol described herein which accommodates thatpotential need for greater inactivation by adjusting the number ofcycles employed; (17) storing eggs in a corn-based bio-plastic cartonafter treatment.
 2. A method of pasteurizing in-shell chicken eggs whichachieves total inactivation of targeted pathogens comprising of: (1)placing the subject eggs within stacked egg flats prior to placing theegg flats within the pasteurization medium; (2) to accommodate theprotocol employed within the pasteurization medium the egg flats containa design which enables a minimum of 95% of each shell of each chickenegg to be exposed to the free flow of a fluid which primarily will beapplied to the subject in-shell chicken eggs through the application offluids which preferably includes water and additives as well as air andadditives appropriate to their individual densities and absorptioncapabilities; (3) the application of fluids to the exposed eggshellswill be applied preferentially through use of sprays of varyingdensities performed by strategically placed nozzles to ensure each eggfully benefits from the exposure to the application of the wateremployed and its corresponding temperatures together with programmedadditives; (4) the application of fluids to the exposed eggshells willbe applied preferentially through use of sprays of varying densitiesperformed by strategically placed nozzles to ensure each egg fullybenefits from the exposure to the application of the air employed andits corresponding temperatures together with programmed additives; (5) asecured environment containing novel features and unique security willbe employed for performing the new and unique art of pasteurization ofin-shell chicken eggs; (6) the pasteurization protocol employed fully isperformed within the confines of a controlled and secured environment ofthe medium which is its most significant and unique feature; (7) themedium performs pasteurization within a secured and controlledenvironment from the point of time of entrance of the subject eggsthrough to and including their exit from the medium; (8) at exit fromthe medium the subject eggs will have been pasteurized to a level ofinactivation of targeted pathogens which is total; (9) the targetedpathogens include primarily but are not limited to all strains ofsalmonella as currently found or anticipated to become found to bepresent within chicken eggs as well as viral strains of contamination ofchicken eggs as so far rarely found within chicken eggs but wheninactivated through employment of pasteurization said anticipatedstrains of viral contamination require a higher level of inactivationthan do salmonella strains; (10) the medium provides the securityrequired to provide for uninterrupted total inactivation of the targetedpathogens through pasteurization without risk of recontamination whichin part is the result of not only the mentioned secured environment butalso is the result of features within the medium which equally areunique to that of the art employed; (11) the art employed provides for aself-sufficient environment within the pasteurization medium which isprogrammed to perpetually cleanse itself through treatment of its air,its temperatures and built in filtration of both fluids employed whetherair with additives or water with additives; (12) further to the abovethe medium benefits from a perpetual and uninterrupted securedenvironment which provides for protection against external contaminationthat is a primary feature of the new art employed. The protocol includesmonitored recirculation of both filtered water and filtered air andtheir reinforcement through the employment of heat to inactivate allstray pathogens which may survive the multiple levels of inactivationprovided within the pasteurization medium. All of the above precautionsare reinforced by constant exposure of pathogens to ultraviolet light orits equal which as a further precaution includes a perpetual monitoring,recording and automated signaling when deviations from the protocolemployed occur; (13) having lost all pathogens present within or uponthe subject eggs through having achieved total inactivation of thetargeted pathogens through the log levels achieved under the new artemployed the subject eggs just prior to exit receive a final shower of afood-grade antibacterial agent which penetrates the exposed eggshellpores to provide a final step of inactivation of stray pathogens; and(14) once the application of the antibacterial agent has been appliedand just prior to the subject pasteurized in-shell chicken eggs reachingambient temperature a food-grade sealant is applied to the eggshellswhich can be selected from either a food-grade wax or a food-gradeplastic; (15) upon conclusion of the above steps and the subject eggshaving been provided with the described inactivation of pathogens theeggs are prepared to be used by the public for unrestricted consumptionwithout risk of illness.
 3. A medium for pasteurizing in-shell chickeneggs which achieves total inactivation of targeted pathogens comprising:stacked egg flats having a design which enables a minimum of 95% of eachshell of each chicken egg to be exposed to the free flow of a fluid;attached nozzles configured to ensure each egg fully benefits from theexposure to the any fluid applied from the nozzles; and a securedenvironment inside which the egg flats are stored.